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Insulin's Role In Making Breast Milk

Written By Alexandros Moumtzis on Τρίτη, 9 Ιουλίου 2013 | 1:50 μ.μ.

The reason so many women have trouble making enough breast milk to feed their newborn is partly because a large proportion of them are prediabetic - insulin dysregulation undermines their milk supply, researchers from Cincinnati Children's Hospital Medical Center and the University of California Davis suggested in PLoS ONE.
In a new study, which adds to their previous one, the scientists explain that insulin plays a major role in lactation success. Lactation is the secretion of milk by the mammary glands.
During lactation the human mammary gland (woman's breast) becomes extremely sensitive to insulin. This is the first study to describe how this occurs, the authors wrote. They added that theirs is also the first study to show specifically which genes are switched on in a woman's breast during breastfeeding.
Study leader, Laurie Nommsen-Rivers, Ph.D., explained that RNA sequencing revealed "in exquisite detail" the blueprint for making milk in the human mammary gland.
Dr. Nommsen-Rivers had demonstrated in a previous study that mothers with markers of sub-optimal glucose metabolism took longer for their milk to come down, suggesting that insulin plays a major role in lactation. Examples of sub-optimal glucose metabolism include being obese, having a very heavy newborn, and being at an advanced maternal age.
This latest study shows how a woman's breasts become sensitive to insulin during lactation.
The milk-making cells in the human breast do not need insulin to take in glucose, which led most experts to believe that insulin played no direct role in lactation.
It is now evident that insulin does a great deal more than simply facilitate the uptake of sugars.
Dr. Nommsen-Rivers said:
"This new study shows a dramatic switching on of the insulin receptor and its downstream signals during the breast's transition to a biofactory that manufactures massive amounts of proteins, fats and carbohydrates for nourishing the newborn baby.
Considering that 20 percent of women between 20 and 44 are prediabetic, it's conceivable that up to 20 percent of new mothers in the United States are at risk for low milk supply due to insulin dysregulation."

Dr. Nommsen-Rivers and team managed to capture mammary gland RNA in samples of human breast milk. RNA, which stands for ribonucleic acid, refers to a chain of molecules that are blueprints for making specified proteins. They then created "the first publicly accessible library of genes expressed in the mammary gland based on RNA-sequencing technology."
Their study revealed a number of genes expressed in human milk-making cells that are highly sensitive. An orchestrated switching off and on of several genes occurs during the transition period between the production of colostrum in the first days after giving birth and the secretion of greater quantities of milk in mature lactation, the scientists discovered.

The PTPRF gene, a biomarker for breastfeeding problems

Protein PTPRF PDB 1lar The PTPRF protein could be a biomarker for breastfeeding problems
The *PTPRF gene may serve as a biomarker for insufficient milk production. This gene is known to suppress signals among cells that are usually triggered by insulin binding to its receptor on the cell surface.
* PTPRF stands for Protein tyrosine phosphatase, receptor type, F.
Nommsen-Rivers and colleagues believe their finding will help researchers in future studies that focus on the physical reasons for breastfeeding difficulties.
Now that they know how important insulin is in the production of breast milk, the team plan to conduct a phase I/II clinical trial with a medication used to control blood sugar in patients with type 2 diabetes. Their primary outcome will be to determine whether this improves insulin action in the mammary gland, i.e. will taking this drug help prediabetic women produce breast milk?
Dr. Nommsen-Rivers acknowledges that medication usage is not the best way to solve the problem of impaired breastfeeding in women with sub-optimal glucose metabolism, but it is ideal for "establishing proof-of-concept through the use of a placebo controlled randomized clinical trial."
Dr. Nommsen-Rivers said:
"The ideal approach is a preventive one," she says. "Modifications in diet and exercise are more powerful than any drug. After this clinical trial, we hope to study those interventions."

Breastfeeding rising in the USA

The US Centers for Disease Control and Prevention (CDC) informed in February 2013 that more American mothers are breastfeeding today compared to ten years ago.
The proportion of mothers who started off breastfeeding increased by over four percentage points from 2000 to 2008. In the year 2000, thirty-five percent of mothers were still breastfeeding at six months, compared to 45% in 2008.
Written by Christian Nordqvist

Dental issues may be early diabetes indicators

Written By Alexandros Moumtzis on Τρίτη, 20 Νοεμβρίου 2012 | 2:32 μ.μ.

If the eyes are the windows to the soul, then your mouth — and, by extension, dental health (or lack thereof) — may be the conduit to potential early warning signs of numerous diseases — including Type 2 diabetes.
Such is the message that both the Palm Beach County Health Department and Florida Public Health Institute’s Oral Health Coalition want patients and dentists to be cognizant of — especially during November’s National Diabetes Awareness Month.
According to Dr. Phil Bilger, the dental director of the Palm Beach County Health Department, in recent years, there’s been a heightened emphasis in the dental community to have everyone — patients and doctors alike — understand how oral health and overall health are related.
“For a long time, dentists treated the mouth as if it was disconnected from the rest of the body,” says Bilger. “Of course, that’s not the case. Each affects the other.”
For example, Bilger cites aggressive, persistent gum and periodontal disease as often being associated with Type 2 diabetes.
“Gum and periodontal diseases are diseases of inflammation that trigger a response in the immune system,” Bilger explains. “But, because diabetes can inhibit the immune system, these diseases in a diabetic might be more resistant to treatment than they would be in a non-diabetic person.”
Thus, whenever gum- or periodontal-disease patients don’t respond as quickly, or successfully, to typical protocols, Bilger suggests that they also visit their medial doctor in order to determine their diabetes status.
A previously undiagnosed patient will often be made aware of his or her own diabetic, or pre-diabetic, condition because of what he or she may believe is a seemingly unrelated dental condition, Bilger says.
Those with Type 2 diabetes, Bilger notes, may also suffer from the following chronic dental conditions:
  • Xerostomia: Colloquially referred to as “dry mouth,” this occurs when a patient has insufficient saliva. This often happens to diabetics because saliva contains glucose — and managing diabetes means limiting one’s glucose level.
  • “Burning mouth syndrome”: Essentially, this is a severe extension of the dry-mouth condition — but far more painful. It may also be accompanied by an inexplicable bitter taste in the mouth, and often worsens as the day passes.
  • Thrush: This is the growth of a naturally occurring fungus that the body can’t control. It results in tender red or white patches, usually on the gums, tongue or roof of the mouth.

What makes treating and curing dental diseases in diabetics particularly challenging, Bilger explains, is that the separate conditions feed off each other: “Having Type 2 diabetes puts you more at risk for developing significant gum disease; meanwhile, having gum disease often makes it harder to control your blood-glucose level. It can be a vicious cycle.”

 sdorfman@pbpost.com

Novo's Degludec Lowers Nocturnal Hypoglycemia Rates

Written By Alexandros Moumtzis on Κυριακή, 1 Ιουλίου 2012 | 12:55 μ.μ.

An experimental insulin from Novo Nordisk A/S (NOVOB) reduced the rate of dangerously low night-time blood sugar levels more than Sanofi (SAN)’s Lantus, a late-stage study showed.
The product, degludec, lowered nocturnal hypoglycemia by 36 percent compared with Lantus, the world’s best-selling insulin, while obtaining equivalent improvement in blood sugar levels over a year, according to a study by Bagsvaerd, Denmark-based Novo that’s being presented today at the American Diabetes Association’s annual meeting in Philadelphia.
The results are further proof that degludec is a better product than Lantus, said Novo Chief Scientific Officer Mads Krogsgaard Thomsen. Paris-based Sanofi says Novo may have designed its trials in a way that favors degludec, an assertion the Danish company contests. The two companies are competing for market share in long-acting insulins amid a global surge in the number of diabetics.
“It’s an amazing set of data,” Thomsen said in a telephone interview. “I have not found any weak spot with degludec. There is no downside.”
Diabetes afflicts 366 million people, killing one every seven seconds, according to estimates by the International Diabetes Federation. The number of people with the disease will increase to 552 million by 2030, caused by an aging population and lifestyle changes in poorer countries, the group says.
Novo’s older product, Levemir, has been trailing Lantus, which last year generated sales of 3.92 billion euros ($4.9 billion). Levemir revenue totaled 7.68 billion kroner ($1.29 billion).

‘Unpredictable, Difficult’

Hypoglycemia can cause unconsciousness, seizures and death, according to the National Institutes of Health.
Night-time hypoglycemia “is a particular challenge for people living with diabetes, as these episodes are often unpredictable and difficult to detect,” Bernard Zinman, lead author of the study and director of the diabetes center at Mount Sinai Hospital in Toronto, said in an e-mailed statement.
Today’s results replicate the findings of two previous studies comparing degludec with insulin glargine, the chemical name for Lantus, Thomsen said. They also show that degludec leads to “significantly” lower rates of severe hypoglycemia compared to Lantus, Novo said.
Both medicines were administered once a day to 1,030 patients with Type 2 diabetes, the most common form of the disease, who hadn’t previously been treated with insulin, according to the statement.

Extended Review

The U.S. Food and Drug Administration extended the review period for degludec by three months after requesting “further data clarification and analyses,” but no additional clinical trials, Novo said yesterday, without being more specific. The FDA is now scheduled to make a decision on the treatment by Oct. 29 instead of July 29, Novo said.
We “have a very robust dataset” for degludec and “we’ve had a very constructive dialogue” with the FDA, Thomsen said.
Novo submitted degludec for approval in the U.S. and Europe in September. It’s also seeking regulatory approval in Japan, Canada, Switzerland and other countries.
Diabetes, caused by a lack of insulin needed to convert blood sugar into energy, can lead to kidney damage, blindness, heart problems and death if left untreated.
Long-acting insulins such as Lantus seek to replicate the steady stream of the hormone that healthy people produce over 24 hours. Degludec has a longer duration of action than Lantus and can be dosed in a more flexible way, according to Novo.

Sanofi’s View

Sanofi has been contesting Novo’s findings on Lantus nocturnal hypoglycemia rates, saying they were influenced by Novo’s trial design.
“Lantus’s scientific records do not support the numbers presented in a comparative way” by Novo Nordisk, Riccardo Perfetti, vice president for medical affairs at Sanofi Diabetes, said in a June 8 telephone interview. The different time of administration of the two insulins might have artificially induced hypoglycemia in Lantus users, he said.
Sanofi’s assertion of a supposedly unfair trial design is“absolutely incorrect,” Thomsen said during the interview.
Degludec is the most immediate threat for Lantus, according to Tim Anderson, an analyst with Sanford C. Bernstein in New York.
“Despite degludec being slightly better, patients and prescribers are generally happy with Lantus and most existing, well-controlled Lantus users are likely to remain on the product,” the analyst wrote in a May 29 note to investors.
“Where Lantus will begin to lose share more quickly is with ‘new patient starts,’ which will lead to market share losses gradually over time,” Anderson wrote.
Novo Nordisk plans to market degludec under the name Tresiba.

Diabetes Drug Actos Linked to Bladder Cancer Again in Study

Written By Alexandros Moumtzis on Δευτέρα, 4 Ιουνίου 2012 | 12:09 π.μ.


diabetes drug actos bladder cancer

Diabetes drug Actos is in the news after a study has again linked the medication to bladder cancer.
 
The diabetes drug, generic name pioglitazone, already carries a warning about bladder cancer risk, but a new study confirms that patients need to be aware of risk when it comes to the drug’s known issues. WebMD quotes researcher Laurent Azoulay, PhD, an epidemiologist at Lady Davis Institute of Jewish General Hospital in Montreal, Quebec in Canada. Azoulay explains:
“Patients with type 2 diabetes and their physicians need to be fully aware of the potential association between Actos and bladder cancer… Certainly, this drug should not be used in patients with a history of bladder cancer and those with other bladder conditions.”
In the study, findings reflected that use of the diabetes drug Actos for more than two years doubles the risk of bladder cancer in people taking the medication. But it was also noted that overall risk of bladder cancer is small as the cancer is uncommon, and overall risk even while taking the diabetes drug was still very small.
Manufacturer Takeda Pharmaceuticals released the following statement to WebMD about the diabetes drug:
“Takeda is confident in the therapeutic benefits of Actos and its importance as a treatment for type 2 diabetes. As a science and evidence-based company, Takeda firmly stands behind the substantial data available confirming the positive risk/benefit profile of Actos, which includes more than 12 years of clinical and patient experience with the product.”
No increased risk of bladder cancer was seen with the similar diabetes drug Avandia. The findings were published in the British Medical Journal.

 

A Metabolic Switch That May Help Diabetes Treatment

Written By Alexandros Moumtzis on Πέμπτη, 17 Μαΐου 2012 | 9:04 π.μ.

Humans are built to hunger for fat, packing it on during times of feast and burning it during periods of famine. But when deluged by foods rich in fat and sugar, the modern waistline often far exceeds the need to store energy for lean times, and the result has been an epidemic of diabetes, heart disease and other obesity-related problems.

Now, scientists at the Salk Institute for Biological Studies have identified the linchpin of fat metabolism, a protein known as fibroblast growth factor 1 (FGF1), which may open new avenues in the treatment of diabetes.

In a paper recently published in Nature, the Evans lab reports that FGF1 activity is triggered by a high-fat diet and that mice lacking the protein swiftly develop diabetes. This suggests that FGF1 is crucial to maintaining the body's sensitivity to insulin and normal levels of sugar in the blood.

"Because humans are good at storing fat during times of plenty, we are also excellent at surviving times of famine," says Ronald M. Evans, a professor in Salk's Gene Expression Laboratory and lead author of the paper. "The fat tissues of our body are like batteries, providing us with a steady source of energy when food is scarce. FGF1 governs the expansion and contraction of fat and thus controls the ebb and flow of energy throughout our body."

Obesity rates have soared in the United States in recent decades, with more than one third of U.S. adults and 17 percent of children and adolescents now considered obese, according to the Centers for Disease Control and Prevention.

As the number of overweight people has grown, so too has the incidence of metabolic disease, with nearly 26 million Americans estimated to have obesity-related type 2 diabetes. With annual costs exceeding well over $200 billion, obesity is a chronic disease that is consuming a huge portion of our health care dollars.

Although exercise and calorie restriction are known to be effective at preventing and treating diabetes, the obesity epidemic continues to grow and new drugs to treat the problem are desperately needed. Against this backdrop, the Evans' lab discovery is an important breakthrough ---- and a surprise.

"The discovery of FGF1 was unexpected ---- and intriguing ---- because it was believed to do nothing," says Jae Myoung Suh, a postdoctoral researcher in Evans' laboratory and co-first author on the paper. "If you deplete FGF1 from the body, nothing happens when the mice are fed a steady low fat diet. But when given a high-fat, "Western-style" diet the mice develop an aggressive form of diabetes and experience a system-wide breakdown of their metabolic health."

"These abnormalities cause abdominal or stomach fat to become inflamed," say Michael Downes, a senior staff scientist in Salk's Gene Expression Laboratory and co-lead author on the paper. "This is important because inflamed visceral fat has been linked to heightened risk for diabetes and other obesity-related diseases, such as heart disease and stroke."

The scientists also found that FGF1 is regulated by the antidiabetic drug Actos, which is used to increase the body's sensitivity to insulin. But Actos and related drugs, though helpful, have side effects that limit their use. Thus, Evans and his colleagues plan to explore whether FGF1 might point to a new way to control diabetes by avoiding the drawbacks of Actos and providing a more natural means of increasing insulin sensitivity.

diabetescare

Heart failure patients with diabetes may benefit from higher glucose levels

Written By Alexandros Moumtzis on Πέμπτη, 10 Μαΐου 2012 | 9:21 π.μ.

Lowering glucose levels for people with diabetes is normally critical to improving health outcomes. But for those with heart failure, that might not always be the case, say UCLA researchers.

A new study found that for advanced heart failure patients with diabetes, having higher blood glucose levels may actually help improve survival rates.

Currently published online in the American Journal of Cardiology, UCLA researchers compared levels of a marker used to track glucose levels called glycosylated hemoglobin in advanced heart failure patients with and without diabetes. The marker is gauged through a simple blood test.

The study assessed the relationship between levels of the marker and mortality outcomes. Researchers found that for heart failure patients with diabetes, for every unit increase in the marker, there was a 15 percent decrease in mortality.

"We were surprised that the optimal level of glycosylated hemoglobin in this patient population with diabetes was higher than levels in current treatment guidelines," said senior author Dr. Tamara Horwich, assistant professor of cardiology, David Geffen School of Medicine at UCLA. "We may find that doctors who treat patients who have both advanced heart failure and diabetes may not need to focus on aggressively lowering blood sugar, but rather keep it under moderate control."

Approximately 25 to 50 percent of patients with heart failure also have diabetes, compared to just 7 percent of the general population. The relation could be due to similar physiologic processes that underlie both conditions such as oxidative stress, patterns of hormonal activity and vascular lining dysfunction that can lead to conditions like atherosclerosis.

For the study, researchers assessed medical records of 845 patients with advanced heart failure, referred to a single university center, the Ahmanson-UCLA Cardiomyopathy Center. Most of the patients (72 percent) were men and the average age was 55.

Patients were classified as having diabetes or not and also grouped by four levels of glycosylated hemoglobin. Using statistical analysis, researchers calculated risk of death or need for an urgent heart transplant.

"For heart failure patients with diabetes, we found that higher, not lower levels, of the marker had better outcomes," said first author Sofia Tomova, a medical student in the division of cardiology, Geffen School of Medicine.

Researchers found that for diabetic heart failure patients, two-year event-free survival was highest amongst patients with the highest elevated glycosylated hemoglobin levels: 65 percent survival rate for patients with level four (greater than 8.6 percent of the marker) and 61 percent survival rate with level three (7.3 to 8.5 percent of the marker).

Patients with lower levels of the marker had worse survival rates: 48 percent survival rate for patients with level one (less than 6.4 percent of the marker) and 42 percent survival rate with level two (6.5 to 7.2 percent of the marker).

According to researchers, the ideal level of glycosylated hemoglobin in heart failure patients with diabetes appeared to be in the 8.3 to 8.9 percent range. Current national treatment targets aim much lower at 7 percent.

In the heart failure patients without diabetes, there was no significant mortality risk difference between the glycosylated hemoglobin levels.

Researchers note that for those without heart failure, having diabetes and elevated glycosylated hemoglobin levels is a risk factor for developing the condition. However, the study shows that if a patient already has heart failure, having higher glycosylated hemoglobin levels may be protective.

The next steps are studies to test the optimal glucose management goals as well as assess the best anti-diabetic medications for heart failure patients with diabetes.

Heart failure affects six million in the United States alone and is caused by weakened heart muscle function that can cause build-up of fluid in the lungs and other organs due to the heart's inability to pump effectively.

University of California – Los Angeles Health Science Press Release

Maternal Obesity, Diabetes Associated with Autism

A major study of the relationships between maternal metabolic conditions and the risk that a child will be born with a neurodevelopmental disorder has found strong links between maternal diabetes and obesity and the likelihood of having a child with autism or another developmental disability.

Conducted by researchers affiliated with the UC Davis MIND Institute, the study found that mothers who were obese were 1-2/3 times more likely to have a child with autism as normal-weight mothers without diabetes or hypertension, and were more than twice as likely to have a child with another developmental disorder.

Mothers with diabetes were found to have nearly 2-1/3 times the chance of having a child with developmental delays as healthy mothers. However, the proportion of mothers with diabetes who had a child with autism was higher than in healthy mothers but did not reach statistical significance.

The study also found that the autistic children of diabetic mothers were more disabled -- had greater deficits in language comprehension and production and adaptive communication -- than were the children with autism born to healthy mothers.

However, the children without autism born to diabetic mothers also exhibited impairments in socialization in addition to language comprehension and production, when compared with the non-autistic children of healthy women. Children without autism of mothers with any of the metabolic conditions displayed mild deficits in problem solving, language comprehension and production, motor skills and socialization.

"Over a third of U.S. women in their childbearing years are obese and nearly one-tenth have gestational or type 2 diabetes during pregnancy. Our finding that these maternal conditions may be linked with neurodevelopmental problems in children raises concerns and therefore may have serious public-health implications," said Paula Krakowiak, a biostatician affiliated with the MIND Institute.

The study, "Maternal metabolic conditions and risk for autism and other neurodevelopmental disorders," is published online in Pediatrics, the journal of the American Academy of Pediatrics. Its authors said that it is the first study to examine the associations between neurodevelopmental disorders and maternal metabolic conditions not restricted solely to type 2 or gestational diabetes, including obesity and hypertension, which have similar underlying biological characteristics, and to investigate correlations between these conditions and impairments in the skills and abilities of children in specific developmental domains.

More than 60 percent of U.S. women of childbearing age are overweight, 34 percent are obese, and 16 percent have metabolic syndrome. Nearly 9 percent of U.S. women of childbearing age are diabetic, and more than 1 percent of U.S. pregnancies were complicated by chronic hypertension. In California, where the study was conducted, 1.3 percent of women had type 2 diabetes and 7.4 percent had gestational diabetes.

Autism is characterized by impairments in social interaction, communication deficits and repetitive behaviors and often is accompanied by intellectual disability. An estimated 1 in 110 children born today will be diagnosed with autism spectrum disorder, and its incidence appears to be growing. An estimated 1 in 83 U.S. children has another developmental disorder, which includes other disorders resulting in intellectual disability.

The study included 1,004 mother/child pairs from diverse backgrounds enrolled in the Childhood Autism Risks from Genetics and the Environment Study (CHARGE), most of them living in Northern California, with a small subset living in Los Angeles. The children were between 24 and 60 months old, born in California and resided with at least one biological parent who spoke either English or Spanish. There were 517 children who had autism; 172 with other developmental disorders; and 315 were developing normally. The participants were enrolled between January 2003 and June 2010.

The researchers obtained demographic and medical information for the mothers and their children using the CHARGE Study Environmental Exposure Questionnaire, a telephone survey, the study participants' birth files and medical records. The primary metabolic conditions of interest were type 2 diabetes or gestational diabetes.

Women were considered diabetic if the condition was noted in their medical records or if during the telephone surveys they answered yes to the questions "During this pregnancy were you ever told by a physician or nurse that you had gestational diabetes?" or "At any time before you became pregnant were you told by a doctor that you had [type 2] diabetes?" The same wording was used to obtain information about hypertension. BMI was calculated using height and weight prior to pregnancy from medical records or telephone interview.

To confirm the developmental diagnoses of the children with autism researchers used the Autism Diagnostic Interview-Revised (ADIR) and the Autism Diagnostic Observation Schedules (ADOS). All of the children were administered the Mullen Sales of Early Learning and the Vineland Adaptive Behavior Scales to assess their cognitive and adaptive development. Spanish-speaking children were administered the tests in Spanish. The participants were then divided into groups of children with autism, developmental disability or normal development.

Among children whose mothers were diabetic during their pregnancies, the study found that the percentage of children with autism born to women with type 2 diabetes or gestational diabetes -- 9.3 percent -- or developmental disability -- 11.6 percent -- was higher than the 6.4 percent of children born to women without these metabolic conditions.

Over 20 percent of the mothers of children with autism or other developmental disability were obese, compared with 14 percent of the mothers of normally developing children.

Approximately 29 percent of the children with autism had mothers with a metabolic condition, and nearly 35 percent of the children with another developmental disorder had mothers with metabolic conditions, compared with 19 percent of the normal children had mothers with a metabolic condition.

The study also examined the link between hypertension and autism or developmental disorder. The prevalence of high blood pressure was low for all groups, but more common among mothers of children with autism or developmental disorder, though the finding did not reach statistical significance.

Analyses of the children's cognitive abilities found that, among the children with autism, children of mothers with diabetes exhibited poorer performance on tests of expressive and receptive language and communication skills of everyday living when compared with the children of non-diabetic mothers. And the presence of any metabolic condition was associated with lower scores on all of the tests among children without autism.

The authors note that obesity is a significant risk factor for diabetes and hypertension, and is characterized by increased insulin resistance and chronic inflammation, as are diabetes and hypertension. In diabetic, and possibility pre-diabetic pregnancies, poorly regulated maternal glucose can result in prolonged fetal exposure to elevated maternal glucose levels, which raises fetal insulin production resulting in chronic fetal exposure to high levels of insulin.

Because elevated insulin production requires greater oxygen use this may result in depleted oxygen supply for the fetus. Diabetes also may result in fetal iron deficiency. Both conditions can adversely affect fetal brain development, the authors said.

"The sequence of events related to poorly regulated maternal glucose levels is one potential biological mechanism that may play a role in adverse fetal development in the presence of maternal metabolic conditions," Krakowiak said.

Maternal inflammation, which accompanies metabolic conditions, may also adversely affect fetal development. Certain proteins involved in cell signaling that are produced by cells of the immune system can cross the placenta from the mother to the fetus and disturb brain development.
University of California – Davis Health System Press Release

Type 2 More Dangerous in Children

Written By Alexandros Moumtzis on Σάββατο, 5 Μαΐου 2012 | 1:31 μ.μ.

Alarming increases of type 2 diabetes in children are no closer to being managed successfully and more aggressive treatment is needed at the start of diagnosis due to the fact that one drug is not enough to control blood sugars....
The study showed that common diabetes-control medications failed to work in children and found that because children develop type 2 diabetes at younger ages, there is an increased lifetime risk for serious complications such as heart attack and stroke. Dr. Terri H. Lipman, co-investigator from the Miriam Stirl Endowed Term Professor of Nutrition and professor of nursing of children, is an expert in pediatric diabetes. Dr. Lipman stated that, "Increases in childhood obesity have yielded an increased incidence of type 2 diabetes in children." "It is important to understand that the epidemic of type 2 diabetes in youth is secondary to high caloric intake and low activity. Both of these causes are a result of a multitude of socioeconomic factors that include food deserts and lack of safe places for activity."

Researchers analyzed 699 overweight children, ages 10 to 17, who were recently diagnosed with Type 2 diabetes, and found that 46 percent of those treated with the drug metformin, commonly used for diabetes control in adults, were not able to maintain healthy blood sugar levels. They needed to begin more powerful insulin injections within slightly less than a year. Among all the study participants, one in five had a serious complication such as very high blood sugar, typically leading to hospitalization. The study also suggested that a healthy lifestyle has little bearing on the effectiveness of treatment.

Healthcare providers began noticing a significant increase in cases of type 2 diabetes in children in the 1990s, especially among blacks and Hispanics from low-income families. The problem started even earlier in American Indians. Data from the Philadelphia Pediatric Diabetes Registry demonstrate that type 2 diabetes is six times more common in black children than in white children. The Philadelphia registry, developed and maintained by Dr. Lipman, is the only such registry in the US operating since 1990.

The purpose of the current study was to identify the best treatment for youth with type 2 diabetes. All participants were overweight, some very obese. All received diabetes education, with the support of a parent or guardian. They were then assigned at random to one of three groups. One group took only metformin, a standard diabetes medication (also called Glucophage). Another took metformin and a second medication, rosiglitazone (also called Avandia). A third group took metformin and went through an intensive diet, exercise, and weight-loss program, which has been successful in adults. All participants were followed for an average of four years.

All three regimens yielded high failure rates and were unable to control blood sugar levels. Metformin alone failed in 52 percent of participants; metformin plus rosiglitazone failed in 39 percent of participants; and metformin plus the diet program failed in 47 percent of participants. Metformin alone was least effective in African-American participants, and metformin combined with rosiglitazone worked better in girls than in boys. The failure rates were high even in the participants who adhered most strictly to their treatment programs.

"There is disappointment that the lifestyle intervention was not more effective, particularly because this intensive intervention included both a personal activity-nutrition leader (a study member acting as a lifestyle coach) and a family member designated for support throughout the intervention," said Dr. Lipman. "What we have learned is that the effect of the obesity-prone environment of these youths is even more difficult to overcome than we had predicted."

While better treatments are needed to manage type 2 diabetes in children, Dr. Lipman said that prevention is key.

"If we are ever to arrest the rise of type 2 diabetes in youth we must intervene with those at risk for this preventable disease," said Dr. Lipman. "This major public health problem must be addressed through collaboration among researchers, clinicians, and community partners."

published online April 29 in the New England Journal of Medicine.

BMI, BUN Can Predict Death from Diabetic Ketoacidosis in Children

Higher BMI and blood urea nitrogen levels are associated with an increased risk for death from diabetic ketoacidosis among children, according to data from a retrospective study.

Suresh Havalad, MD, associate professor of pediatrics at Chicago Medical School and division director of Pediatric Critical Care at Advocate, analyzed data for all children aged younger than 19 years who presented to the hospital with diabetic ketoacidosis who survived (controls, n=122) and died (cases, n=10) during a 6-year period.

They analyzed medical charts and autopsy reports and collected data on sample and treatment characteristics, serum chemistries, and histological or radiographic evidence for cerebral edema. Case-control comparisons were conducted using multivariate logistic-regression models and selected clinical parameters, including serum glucose, creatinine, blood urea nitrogen (BUN), calculated osmolality and BMI.

Death from diabetic ketoacidosis was significantly associated with BMI (OR=1.18; 95% CI, 1.07-1.31), BUN (OR=1.11; 95% CI, 1.04-1.18), glucose (OR=1; 95% CI, 1-1.01), creatinine (OR=3.94; 95% CI, 1.51-10.33) and calculated osmolality (OR=1.06; 95% CI, 1.03-1.08) in univariate analysis. In multivariate model, however, significant predictors of mortality were only BMI (OR=1.14; 95% CI, 1.03-1.27) and BUN (OR=1.09; 95% CI, 1.01-1.18).

Using established criteria for obesity and azotemia, children with diabetic ketoacidosis were more likely to die if BMI was .30 (OR=30.83; 95% CI, 5.35-177.36) and BUN was .40 mg/dL (OR=98.4; 95% CI, 9.23-1049.17).

Despite the small sample size, the results suggest that children with higher BMI and BUN are at increased risk of death from diabetic ketoacidosis. Further study is needed to confirm and extend these findings," the researchers wrote in their abstract.

Presented at: 2012 Pediatric Academic Societies Annual Meeting; April 28-May 1; Boston. Vaikom House AK. Abstract #1515.272

SICK-DAY RULES

Written By Alexandros Moumtzis on Πέμπτη, 5 Απριλίου 2012 | 11:25 μ.μ.



SICK-DAY RULES

Children with intercurrent illnesses, such as infections or vomiting, should be closely monitored for elevations in blood glucose levels and ketonuria. On sick days, blood glucose levels should be checked every 2 hours and the urine should



be checked for ketones with every void. Supplemental doses of short-acting insulin

(0.1 to 0.3 units/kg) should be given every 2 to 4 hours for elevations in

glucose and ketones. Because of its more rapid absorption, lispro will lower

plasma glucose faster than Regular insulin. If the morning dose has not been

given and the child has a modestly elevated glucose level

(150 to 250 mg/dI),



small doses of NPH can be given to avoid too rapid a fall in plasma glucose

levels. This works especially well in young children whose glucose levels fall

quickly with rapid-acting insulin. Adequate fluid intake is essential to prevent

dehydration. Ruids such as flat soda, clear soups, popsicles, and gelatin water

are recommended to provide some electrolyte and carbohydrate replacement. If

vomiting is persistent and ketones remain moderate or high after several supplemental

insulin doses, arrangements should be made for parenteral hydration and

evaluation in the emergency department.

Children receiving Ultralente insulin seem to be prone to the development

of hypoglycemia and ketonuria during episodes of gastroenteritis.

If the child is



unable to retain oral carbohydrate, then small doses of glucagon (i.e.,

0.1-0.2



mg), given subcutaneously every 2 to 4 hours, can be used to maintain normal

blood glucose levels.

Parents are told from the time of diagnosis that vomiting is a diabetes emergency

and tllat tlley need to call for help after first checking blood glucose and

urine ketone levels. This is especially true for children on pump therapy, since

a catheter occlusion can throw the child into ketosis rapidly.

If a pump-treated



patient has elevated glucose and ketone levels, they are instructed to take a bolus

injection of lispro insulin

by syringe. The dose of insulin varies between 0.2 and



0.4 units per kilogram. They are then instructed to change their infusion set and

to program a temporary basal rate at twice the usual basal rate for

4-5 hours.



If the child does not feel like eating regular meals you should still try to convince him or her to eat regular amounts of carbohydrates.

Offer food the child likes, such as ice cream, fruit or soup.

Type 1 Diabetes Researchers Reach Important Milestone

Written By Alexandros Moumtzis on Παρασκευή, 30 Μαρτίου 2012 | 1:08 π.μ.

This press release is an announcement submitted by , and was not written by Diabetes Health.
Type 1 Diabetes TrialNet, an international network of researchers exploring ways to prevent and delay the progression of type 1 diabetes, has reached an important milestone: screening 100,000 people to detect who among is at risk of developing type 1 diabetes. This is a major achievement because it has helped researchers better predict who will develop diabetes and when it will require treatment. Earlier diagnosis helps patients avoid a severe, life-threatening condition called diabetic ketoacidosis.
Funded by the National Institutes of Health (NIH), TrialNet screenings are provided free of charge to relatives of people with type 1 diabetes- whose chances of developing the disease are 15 times greater than those with no family history. Participants whose results signal an increased risk can choose whether to take part in prevention studies exploring new ways to combat the disease.
TrialNet researchers are currently conducting two prevention studies for at-risk relatives of people with type 1 diabetes:
• The Anti-CD3 Prevention Study is testing whether an experimental drug called teplizumab can prevent or delay type 1 diabetes. In previous studies, teplizumab helped preserve insulin production in newly diagnosed individuals.
• The Oral Insulin Prevention Study is testing whether one daily insulin capsule (taken by mouth) can prevent or delay type 1 diabetes. Results of a previous NIH study indicated oral insulin might delay type 1 diabetes for up to 10 years in individuals with certain autoantibodies.
"Screening is the first step on the pathway to prevention and provides an important opportunity for intervention at an early stage," says TrialNet Chair Jay Skyler, M.D.
Incidence of type 1 diabetes is rapidly increasing worldwide. The disease is also presenting at an earlier age, with the greatest increase in children under age five. Each year, in the U.S. alone, approximately 15,000 children and adolescents are diagnosed with type 1 diabetes. While peak ages for diagnosis are between 11 and 14, type 1 diabetes can occur at any age. Unlike type 2 diabetes, which may be controlled and even prevented with diet and exercise, there's currently no cure for type 1 diabetes, an autoimmune condition requiring lifelong insulin injections.
"TrialNet is committed to going the distance to screen relatives of people with type 1 diabetes until we find a way to prevent this disease," says Skyler.
Dora Lenord
Mar 28, 2012
from diabetes health

Using A1c Test is Cost-Effective to Diagnose Prediabetes

Written By Alexandros Moumtzis on Κυριακή, 25 Μαρτίου 2012 | 7:48 μ.μ.

 Για να μη λέτε οτι μόνο εμείς κάνουμε περικοπές γιατί only the money counts!!! unfortunatly :(
Using A1c to catch prediabetes is cost-effective if the threshold for diagnosis is set at 5.7%....
The cost of treating patients for an HbA1c level less than 5.7% would likely outweigh the savings from improvement in long-term outcomes, according to an analysis by Xiaohui Zhuo, PhD, of the CDC in Atlanta, and colleagues largely at the same agency.

Those diagnostic cutoffs wouldn't fall within the $50,000 per quality life-year gained, typically considered cost-effective.

"Lowering the cutoff from 5.7% to 5.6% also may be cost effective, however, if the costs of preventive interventions were to be lowered," the group noted.

The threshold for diagnosing prediabetes became controversial in 2009, when the American Diabetes Association recommended using hemoglobin A1c as the new standard diagnostic test for diabetes and prediabetes.

That organization indicated 6.5% as the cutoff for frank diabetes, but the level indicating prediabetes has variably been set anywhere from 6.0% to 5.5% by different professional groups.

"Establishing an A1c cutoff for prediabetes, however, has been more challenging than for diabetes because the relationship between the incidence of type 2 diabetes and A1c below 6.5% is continuous, with no clearly demarcated threshold that is associated with an accelerated risk of diabetes or other morbidities," Zhou's group explained.

They ran simulations using a nationally-representative sample of the nondiabetic adult population in the National Health and Nutritional Examination Survey (NHANES 1999 to 2006), modeling the impact of each 0.1% increment in the threshold for prediabetes from 6.4% to 5.5%.

Each lower threshold progressively improved health of the population considered over a lifetime from the healthcare system perspective but also increased costs.

Assuming that prediabetes found in that population was treated with a higher-cost approach similar to that seen in the Diabetes Prevention Program study averaging about $1,000 a year, moving the cutoff for prediabetes diagnosis as low as 5.7% was cost-effective.

The cost per quality life-year gained was:

  • $27,000 to go from 6.0% to 5.9%
  • $34,000 to further drop from 5.9% to 5.8%
  • $45,000 to go from 5.8% to 5.7%

But bringing the threshold for diagnosis down further exceeded the $50,000 mark per quality life-year gained, at $58,000 to go from 5.7% to 5.6% and $96,000 to go from 5.6% to 5.5%.

The numbers were better assuming use of lower cost interventions averaging about $300 per year to treat prediabetes as in the Promoting a Lifestyle of Activity and Nutrition for Working to Alter the Risk of Diabetes (PLAN4WARD) study.

The cost per quality life-year gained in that analysis was just $24,000 to lower the HbA1c cutoff from 6.0% to 5.9% and $34,000 to get down to 5.7%.

Even going from 5.7% to 5.6% would be considered cost-effective in that less expensive scenario, costing $43,000 per quality life year gained, although the next increment to 5.6% wasn't at $70,000.

The group cautioned that use of hemoglobin A1c for diagnosis isn't universally agreed upon and does have some limitations.

The Artificial Pancreas Works!

Written By Alexandros Moumtzis on Σάββατο, 17 Μαρτίου 2012 | 10:47 π.μ.

In January, Elle, a type 1 normal teenager, walked into Massachusetts General Hospital to start the trial. Doctors fitted her for an artificial pancreas hooked up to a laptop, but in the future, the device will be the size of a cell phone....
Dr. Steven Russell, an instructor at Harvard Medical School stated that, "For three days, the device did the work Elle's pancreas can no longer do." "It went very smoothly -- her blood sugar control was really very, very good, and we were really very pleased by what we saw with Elle."

Russell's research partner, Edward Diamano, an associate professor of biomedical engineering at Boston University, says the device learned Elle's blood sugar patterns and made changes accordingly. "It's making adjustments every five minutes," he says.

For that one weekend, Elle didn't have to draw blood, and she could eat foods she hadn't eaten in large quantities for four years. "She ate Spaghetti-O's and grilled cheese and French fries and hamburgers," her mother, Stefany Shaheen, said. "She ate between 67 and 100 grams of carbs [every meal], and usually she can only eat between 40 and 50."

Then, after the experiment, Elle had to leave the artificial pancreas behind, and it was back to counting carbs and poking herself every couple of hours. Her mother reset the nighttime alarm clock.

"We're extraordinarily impatient for access to the device," Shaheen says. "I think it will revolutionize the way she lives."

Two weeks ago, Russell and Damiano visited the Food and Drug Administration offices, to show regulators a prototype for the artificial pancreas. The device itself can be worn in a pocket or clipped to a belt. Two tiny pieces go under the skin, one to detect glucose levels in the blood and another to deliver insulin and glucagon, a drug used to raise very low blood sugar.

Algorithms determine how much insulin and glucagon the patient needs, and if necessary the patient can manually override the device.

So far, the FDA has required doctors to keep patients inside the hospital while they're using the device.

Dr. Charles Zimliki, who chairs the FDA's Artificial Pancreas Critical Path Initiative, testified before a Senate committee last year. The potential benefits are enormous but, he said, "if not properly designed, use of an artificial pancreas device in an outpatient setting can place patients at significant risk."

Russell said he hopes that by the fall, the FDA will give him permission to allow adult diabetic patients to leave the building and walk the grounds of the Massachusetts General Hospital campus accompanied by a nurse, eating as they like and using the hospital's gym.

Then by the summer of 2013, he hopes to give the artificial pancreas to children attending a summer camp. "These are all baby steps towards what we ultimately want to do, which is give them the device and say, 'Go home and check back with us in a week,' " Russell says.

JDRF.org JDRF is funding artificial pancreas trials at 13 sites worldwide, including Yale University, Stanford University, the University of Virginia and the University of Colorado.

Stop Using Sulfonylureas?

Written By Alexandros Moumtzis on Σάββατο, 10 Μαρτίου 2012 | 9:21 μ.μ.

The ACP has issued a clinical practice guideline regarding use of oral agents in type 2 diabetes entitled, "Oral Pharmacologic Treatment of Type 2 Diabetes Mellitus: A Clinical Practice Guideline From the American College of Physicians."...
This is important because despite new therapies, there hasn't been a guideline from either the ADA or AACE in a while. Of note, the more recent AACE/ACE guideline from a few years ago says that metformin is probably best, but you can start with whatever you want, except for sulfonylurea. The actual ADA guideline says start with metformin and then add either SU, TZD or insulin. A consensus statement (not guideline) from the author of the ADA guideline changed things to start with metformin and then add SU or insulin.

The ACP guideline first reviewed all the literature comparing different diabetes agents alone or in combination and looked at outcomes beyond A1c reduction. This is known as comparative effectiveness, and we should expect to see a lot more of this in the US, although the UK has been doing this for some time.

A summary of the ACP's three recommendations are as follows:

  • Recommendation 1: Use medications in patients diagnosed with type 2 diabetes when lifestyle modifications aren't working
  • Recommendation 2: Start with metformin in most patients with type 2
  • Recommendation 3: Add a second agent when metformin alone is not enough.

This is all based on high quality evidence. Unfortunately the evidence comparing agents other than metformin was less than robust, and they could not really recommend one agent over another. This suggests that physicians, after starting on metformin, can choose a second agent based on properties of those specific agents that may be beneficial to a particular patient (i.e. GLP-1 analogues for overweight patients), avoid agents with unwanted side effects (i.e. not using TZD's in patients with fluid overload) as well as other factors such as cost and patient preference.

Though the recommendations don't clarify much other than to start with metformin, statements in the discussion section do clarify one thing:

According to the ACP, "The evidence shows that most diabetes medications reduced HbA1c levels to a similar degree. Metformin was more effective than other medications as monotherapy as well as when used in combination therapy." "High-quality evidence shows that the risk for hypoglycemia with sulfonylureas exceeds the risk with metformin or thiazolidinediones."

In other words, though not exactly stated as a major recommendation, it appears that physicians should start with metformin, then add something else (TZD, DPP4, GLP-1, SGLT-2 -when available), but probably not sulfonylurea, since it clearly causes more hypoglycemia than anything else.

SU's are effective, but not good medications. They cause significant hypoglycemia. They cause weight gain. They "burn out" the pancreas. All of the others do not cause hypoglycemia. All except for TZD's are weight neutral or cause weight loss. All the other appear to preserve beta cell function. The only reason to use SU's in 2012 is due to cost. However, in the US most of the branded combination pills come with a coupon card that would take the cost to the same as adding an SU. Kombiglyze XR (DPP4+ Met) is once a day and has a coupon card that takes the out of pocket cost down to $10. Janumet XR has a $5 coupon card.

Given all the evidence, plus practical ways for patients to reduce the costs of branded diabetes medications, is there any reason to use sulfonylureas as anything more than a 3rd or 4th line agent?

American College of Physicians, Feb 2012

FDA Advisors Recommend Approval of Obesity Drug Qnexa

Written By Alexandros Moumtzis on Σάββατο, 3 Μαρτίου 2012 | 2:46 μ.μ.

The FDA Endocrinologic and Metabolic Drugs Advisory Committee voted overwhelmingly (20 to 2) in favor of approving the obesity drug Qnexa (Vivus, Inc.), a combination of phentermine and controlled-release topiramate. Qnexa could be the first prescription drug for obesity to reach the market since 1999....
The panel voted 20 to 2 in favor of approving Qnexa, stating that the risk/benefit ratio is appropriate in patients with a body-mass index (BMI) of >30 kg/m2 or >27 kg/m2 in patients with weight-related comorbidities. Despite some concerns over increases in heart rate, as well as concerns about potential birth defects in babies born to women taking the drug, particularly risks of cleft lip with or without palate, the panel felt the risks of untreated obesity outweighed these concerns.

"Obesity is in epidemic proportions in the US, with serious morbidity and mortality consequences, and there is an urgent need for better pharmacological options for individual patients," advisory committee panelist Dr. Elaine Morrato (University of Colorado, Aurora), who voted yes for the approval, said in explaining her affirmative vote. "I believe that Qnexa demonstrated a meaningful efficacy benefit and that there are consequences to not treating obesity."

Despite the dramatic vote in favor of approval, the panel strongly recommended the initiation and completion of a large morbidity and mortality study to address any potential cardiovascular risks, as well as the use of a risk evaluation and mitigation strategy (REMS) to accompany approval. One of the questions the panel grappled with was whether or not a cardiovascular-outcomes study would be required prior to approving the Qnexa. On the whole, most committee members did not believe the clinical trial was needed to approve the drug, stating that a postapproval study would be sufficient.

Dr. Sanjay Kaul (Cedars Sinai Medical Center, Los Angeles, CA), who also voted yes on approval, said the sponsor demonstrated sufficient efficacy with Qnexa, "but now they need to step up to the plate and do the cardiovascular-outcomes trial and do it fast." He urged the FDA to hold the sponsor's "feet to the fire" and use its legislative authority to ensure that the study is done in a timely manner.

In contrast, Dr. Michael Lauer (National Heart, Lung, and Blood Institute, Bethesda, MD), one of two voices against approval, said he was concerned about approving Qnexa on the basis of surrogate outcomes only, saying the approval would be a mistake based on hope and suppositions.

"We've seen many cases in the history of medicine where we thought we understood the physiology or pathophysiology of disease and made policy decisions on the basis of that, and it turned out to be wrong once we actually looked," said Lauer. "As a result, we caused an enormous amount of harm. In an epidemic as serious as obesity, we really need to do this right. We should have no trouble getting a trial put together and finding high-risk patients to answer this question [about cardiovascular risk]."

He cited torcetrapib, the HDL-raising medication that moved surrogate end points in all the right directions but still increased the risk of mortality. Based on the data, Lauer said there is good reason to believe that Qnexa has the potential to do enormous good, but this won't be known for a long time.

"There is a real possibility that this agent, with the data we have available to us, may help people lose weight, may make the chemistry test look better, but it may end up causing heart attacks, stroke, or higher death rates. It would be a terrible, terrible shame if that were to happen and we didn't take the appropriate precautions."

Dr. Jenny Cragan (University of Pennsylvania School of Medicine, Philadelphia) said the Qnexa recommendation was a more difficult decision than the 20 to 2 vote suggests. Like others, she urged the completion of the cardiovascular-outcomes study, the implementation of the REMS, and further evaluation of data to fully assess and characterize the risk of birth defects. Dr. Lamont Weide (University of Missouri, Kansas City) also voted yes, saying that Qnexa is the most efficacious drug that has come to market. Still, he expressed concerns similar to Lauer's and the rest of the panel's.

Although it is not clear when the clinical trial will be started or even if it will be a condition of approval, Vivus did provide some details of a study that would address the panel's concerns. The outcomes trial would include approximately 11,000 patients at high risk for cardiovascular disease or patients with cardiovascular disease. The company also hinted at the possibility of including intermediate-risk patients, such as those with diabetes mellitus, hypertension, or dyslipidemia, in the hopes of enrolling patients faster. The primary end point of the study would likely be a composite of death/MI/stroke.

This isn't the first time Qnexa has come before the advisory committee. In July 2010, the panel voted against the approval of the drug because of concerns about its safety, and this led the FDA to reject it. At the time, most panelists, many of whom served again on yesterday's panel), agreed the drug was effective at promoting weight loss but were disconcerted by the number of adverse events linked to the drug, including cognitive disorders, metabolic acidosis, increased heart rate, and birth defects.

Again, the efficacy was never in doubt for yesterday's committee. One-year data showed that low-, mid-, and high-dose Qnexa was associated with a large percentage of patients losing more than 5% of their body weight, while two-year data, which was requested by the FDA, showed that patients treated with mid- and high-dose Qnexa lost 9.3% and 10.5% of their body weight from baseline. There was an increase in weight, however, observed in the second year of treatment. Surrogate markers also moved in the right direction, too, with Qnexa-treated patients having reductions in blood pressure, HbA1c levels, and improvements in lipid parameters, including HDL cholesterol.

The two concerns the advisory committee had with Qnexa were related to the increases in heart rate and the increased risk of cleft lip with or without cleft palate. The drug appears to increase heart rate 1 to 2 beats per minute and, based on FDA analyses, increases the risk of cleft lip two- to fivefold among children born to women taking topiramate.

As part of the proposed REMS, the sponsor stressed the importance of adequate birth control in women taking Qnexa and recommended pregnancy testing before and during drug treatment and stopping the drug immediately if a pregnancy occurs. As part of the REMS, they also proposed controlled distribution and provider training and the use of communication tools to inform patients, physicians, and pharmacists about the risk of congenital malformations with the antiobesity agent.

The inclusion of the REMS as part of approval appeared to satisfy panel members enough to vote yes, including some who reversed their 2010 vote.

Morrato noted that the active ingredients in Qnexa have been marketed for years including the use of topiramate for the treatment of epilepsy and migraine headaches and that these drugs individually carry side effects. She added that the population-attributable risk with Qnexa could be quite large given the large numbers of patients, possibly tens of millions, who are likely to be treated with the weight-loss drug. She voted no to approval in 2010 because of the lack of an adequate risk-management plan and an inadequate focus on ensuring that only patients with an appropriate risk profile would be treated.

With the REMS, and the proposed morbidity and mortality trial with Qnexa, "I believe the sponsor and the FDA are striving to find the right balance to provide access to effective antiobesity medications and mitigating the risks," said Morrato.

If the FDA ends up following the advice of its advisors, Qnexa could be the first prescription drug for obesity to reach the market since 1999. Experts called to present data and perspectives on behalf of Vivus argued that there is an unmet clinical need in the management of obesity. In particular, they said Qnexa could fill a need between the use of lifestyle changes and surgery to achieve weight loss. While bariatric surgery cuts weight by 20% to 30%, there is a need for a treatment that can reduce body weight in the range of 5% to 20%, which is more than lifestyle changes alone can achieve, they said.

Food and Drug Administration clinical briefing document. Endocrinologic and metabolic drugs advisory committee meeting, February 22, 2012. Available here.

Unnecessary, Expensive Tests Used to Diagnose Neuropathy

The high cost of diagnosing peripheral neuropathy could be greatly reduced if doctors ordered the right tests....
Lead author, Brian Callaghan, MD, from the University of Michigan Medical School, Ann Arbor stated that, a survey of the tests used to diagnose neuropathy showed that almost one quarter of patients undergo high-cost, low-yield magnetic resonance imaging (MRI), while few patients get the inexpensive, high-yield glucose tolerance tests advocated by current guidelines.

"We order some expensive tests that probably are not needed, and we don't order some of the cheap tests that probably are," Dr. Callaghan said. "The glucose tolerance test, a cheap blood test looking for diabetes and pre-diabetes, is almost never done, and the MRIs are often done but rarely needed."

Dr. Callaghan said it became clear to him during his training that neurologists varied a great deal in the way they evaluate a patient for peripheral neuropathy.

This observation prompted the current study. In it, he and his team used the 1996-2007 Health and Retirement Study-Medicare claims database to identify individuals with a diagnosis of peripheral neuropathy. They focused on 15 relevant tests and examined the number of patterns of tests 6 months before and after the initial diagnosis.

Of the 12,673 patients in the database, 1031 (8.1%) were diagnosed with peripheral neuropathy during the 10-year study period. The patients' mean age was 77.6 years, 54.0% were female, 41.5% met the Chronic Condition Data Warehouse definition of diabetes, and 16.3% had diabetic complications.

Each patient had a median of 4 diagnostic tests, with an interquartile range of 2 to 5 tests.

The study found that MRI of the brain or spine was the test most commonly done, in 23.2% of the patients. A glucose tolerance test was done in only 1.0% of patients.

The study also found that in the period before neuropathy was diagnosed, the mean Medicare expenditures were $8067. During the diagnostic period, the mean expenditures significantly increased, to $14,362 (P < .001).

When the researchers excluded patients with diabetes in determining the mean Medicare expenditures, the increase was still observed (mean, $12,190 vs $6633; P < .001).

Other tests that were done included a fasting glucose level in 23.4% of patients, a hemoglobin A1c in 43.2%, vitamin B12 levels in 32.6%, and serum protein electrophoresis (SPEP) in 13.3%.

The fasting glucose level, B12 level, and SPEP, which are tests supported by the American Academy of Neurology (AAN) practice guidelines, were ordered less frequently than expected, Dr. Callaghan said.

"I agree with the AAN guidelines that say we should be getting a glucose tolerance test, a B12, a serum protein electrophoresis, and that we should limit the rest of the tests that we order," he concludes.

In a commentary, A. Gordon Smith, MD, from the University of Utah School of Medicine, Salt Lake City, called the study "important" and said it provides "strong evidence that the history and examination are both indispensable and cost-effective."

"We must take more time to listen to our patients, use our clinical 'senses,' and follow evidence-based guidelines for diagnostic testing," he concludes.

Arch Intern Med. Jan. 23, 2012;172:127-132, 132-133

New ACP Guidelines for Type 2 Diabetes Treatment

Written By Alexandros Moumtzis on Σάββατο, 25 Φεβρουαρίου 2012 | 6:26 μ.μ.

Metformin should be the initial drug for most patients with type 2 diabetes refractory to lifestyle modifications, with a second drug added if needed, according to a new clinical practice guideline from the ACP....
The new recommendations from the American College of Physicians (ACP) are based on a systematic evidence review and comparative efficacy analysis of FDA-approved oral medications for the treatment of type 2 diabetes (metformin, sulfonylureas, meglitinides, thiazolidinediones, DPP-4 inhibitors, and GLP-1 receptor antagonists).

Lead author Amir Qaseem, MD, FACP, PhD, MHA, director of clinical policy at the ACP said, "We found that most diabetes medications reduced blood sugar levels to a similar degree." "However, metformin is more effective compared to other type 2 diabetes drugs in reducing blood sugar levels when used alone and in combination with other drugs. In addition, metformin reduces body weight and improves cholesterol profiles."

The guideline authors searched MEDLINE (updated through December 2010), EMBASE, and the Cochrane Central Register of Controlled Trials for trials that compared diabetes drugs head-to-head and were published in English-language journals between 1966 and April 2010. The researchers assessed clinical outcomes including death from any cause, cardiovascular disease and death, cerebrovascular morbidity, neuropathy, nephropathy, and retinopathy. The ACP clinical practice guidelines grading system allowed grading of the recommendations and underlying evidence.

Specific recommendations in the new guidelines are:

  • Recommendation 1: When diet, exercise, weight loss, and other lifestyle modifications have not adequately improved hyperglycemia, clinicians should add oral pharmacologic therapy in patients with type 2 diabetes (grade: strong recommendation, high-quality evidence).
  • Recommendation 2: For most patients with type 2 diabetes, initial pharmacologic therapy should be monotherapy with metformin (grade: strong recommendation; high-quality evidence).
  • Recommendation 3: When lifestyle modifications and monotherapy with metformin fail to control hyperglycemia, clinicians should add a second drug to metformin (grade: strong recommendation; high-quality evidence).

Overall adverse effects were fewer with metformin than with sulfonylureas, and high-quality evidence showed that risk for dangerous levels of hypoglycemia was higher with sulfonylureas than with metformin or thiazolidinediones. In addition, the combination of metformin plus sulfonylureas is associated with 6-fold greater risk for hypoglycemia than the combination of metformin plus thiazolidinediones. When used as monotherapy, the risk for hypoglycemia with metformin and thiazolidinediones was similar, based on moderate-quality evidence.

Evidence was insufficient regarding any efficacy difference among various medications across subgroups of adults based on age, sex, or race.

The ACP recommended generic metformin because of its better efficacy and fewer adverse effects than most other available medications, lack of associated weight gain, and lower cost.

The guideline authors wrote, "It was difficult to draw conclusions about the comparative effectiveness of type 2 diabetes medications on all-cause and cardiovascular mortality, cardiovascular and cerebrovascular morbidity, and microvascular outcomes because of low-quality or insufficient evidence." "Metformin is associated with an increased risk for gastrointestinal side effects. Thiazolidinediones are associated with an increased risk for heart failure, and both rosiglitazone and pioglitazone are contraindicated in patients with serious heart failure."

Practice Pearls

  • Note that in a new guideline, the American College of Physicians (ACP) recommends monotherapy with metformin as the initial pharmacologic therapy for most patients with type 2 diabetes.
  • Note that the ACP recommends the addition of a second agent when patients have persistent hyperglycemia despite metformin and lifestyle modification.

Ann Intern Med. 2012;156:218-231.

Is Obesity Really A Modern Epidemic?

Written By Alexandros Moumtzis on Τετάρτη, 22 Φεβρουαρίου 2012 | 8:49 π.μ.

Recent studies have considered obesity as a modern epidemic, with many adverse effects on a person's health, such that researchers continue to focus on issues relating to obesity particularly the role of exercise in maintaining a healthy body.
One study focuses on the relationship between body mass index (BMI) and poor health. Researchers Green and Maiorana points out that exercise and fitness are better than obesity for predicting cardiovascular and all-cause mortality, and that improved fitness has benefits that are independent of weight reduction.
Green and Maiorana acknowledge that there is a place for bariatric surgery, but believe that exercise and fitness should still be prescribed because in itself it is good for the individual, regardless of weight loss. The authors argue that, if emerging indications of epigenetic influences on lifelong weight control are borne out, the need to acquire good exercise habits at a young age is vital .
Another study by Skouteris and colleagues noted that it does indeed seem to be good to start young. Looking at existing guidelines for physical activity in preschoolers, they said that the guidelines are inconsistent, and their basis uncertain. They added that there is a lack of information about what is a normal level of activity, and a lack of knowledge about what activity should be measured and how to measure it.
According to Morley and colleagues, nearly one in four Australian adolescents are overweight or obese. Those with the highest risk are characterized as male, less wealthy, inactive, sleep-deprived and frequently hooked to a computer or TV. The most important factor was found to be low socioeconomic status, but the way this is associated with obesity is still to be ascertained.
One thing Rissel and colleagues have confirmed is a significant association between soft drink consumption and obesity in school students.
McIntyre and colleagues argue that overweight and obesity are now endemic in pregnant women. They found that, despite some missing data, the overall prevalence of overweight and obesity had increased little over a decade, but the obese had become more obese. In a large cohort, about one in 20 pregnant women had a BMI of 35 kg/m2 or higher. As with adolescents, obesity was associated with lower socioeconomic status.
The authors confirm that being overweight or obese confers significant maternal and neonatal risk, requiring more obstetric resources. From an obstetric point of view, it is challenging to care for people who are this large, and more challenging to safely deliver their babies. Women need to know that obesity, like tobacco and alcohol, is a risk factor in pregnancy.
Despite all the unknowns in our understanding of overweight and obesity, the simple principle of energy in and energy out should underpin much of our thinking. Magarey provides some practical suggestions for redressing the imbalance between food consumption and exercise that is so prevalent in our society. If we want our children to enjoy a long and healthy life, we need to work on this equation.
To contact the editor, e-mail: editor@ibtimes.com
source: Business and Health

5 Superfoods You Should Eat—but Probably Don't

Written By Alexandros Moumtzis on Τρίτη, 21 Φεβρουαρίου 2012 | 1:17 π.μ.

What makes a food “super”? If you believe what you see in the grocery store, superfoods are everywhere these days: goji berries, acai juice, wheatgrass, seaweed—many of them exotic ingredients pitched with promises of weight loss, smoother skin, an energy boost, or even a healthier heart. But despite the marketing, there’s little to no proof that the food fad of the moment will improve your health. Most people will do best with a diet that derives nutrients from a variety of whole food sources.
Still, there are some foods that deserve the superlative treatment because they have been scientifically shown to contain high amounts of the good stuff—like vitamins, minerals, and proteins. The following five are all proven sources of nutrients your body needs, no gimmicky mumbo jumbo required.
Beets
If vegetables were judged solely on looks, deep purple-red beets would be a perennial favorite. The root veggies’ jewel-toned flesh is popular with restaurant chefs because it adds excitement to a dish. “They’re beautiful [and] they dress up a plate, and you know we eat with our eyes,” says Joan Salge-Blake, MS, RD, LDN, a clinical associate professor at Boston University and author of Nutrition & You: Core Concepts to Good Health. Buy firm beets with the greens intact (they’re edible, too, and keep the bulb fresh) and they’ll last a week in the refrigerator. When you’re ready to cook them, wash the bulbs under water to remove dirt—but keep the skin on. After you bake and cool the beets, you can rub or peel the skin right off.
Why They’re Worth It
Beets are high in vitamin C and folate. Plus, they’re a great source of the antioxidant lipoic acid. “Recent research shows it can be helpful in healing nerve damage in people with diabetes,” says Salge-Blake.
How to Cook
The easiest way to cook beets is to roast them in the oven, which brings out the vegetable’s natural sweetness. To roast, cut the greens from the bulb, leaving about an inch of stem. After washing, place the beets in a baking pan and add ¼ of an inch of water. Cover with aluminum foil, and roast at 400 to 450 degrees until you can easily insert a knife in the beet. Once the beets are cool, peel the skin away. (Beets tend to bleed, and the juice can stain, so use caution.) Slice roasted beets and put them in a salad. Or cut them into cubes and toss with balsamic vinegar, olive oil, dill, and crumbled goat cheese, as Ryan Hutmacher, chef and owner of Centered Chef Food Studios in Chicago, does. He also likes to incorporate beets into traditional foods. “If somebody doesn’t like beets, you can introduce beets to people through pancakes,” Hutmacher says. Shred roasted beets finely with a grater (or use a food processor), then add to the batter.

Sardines
If you’ve given salmon and tuna a try, why not taste sardines? For starters, sardines are an environmentally sound alternative to overfished salmon and have lower mercury levels than larger fish like tuna. You can buy the small, silver-fleshed fish fresh, but if you don’t plan to eat them soon, opt for canned.
Why They’re Worth It
Like other fatty fish (such as salmon), sardines contain heart-healthy omega-3 fatty acids. “[You] want to be having two fish meals per week because that’s going to lower your risk for heart disease,” says Salge-Blake. Sardines are also high in protein, so they’re a great add-on to veggie-heavy dishes. When it comes to canned sardines, you can pick between those packed in water and those in oil. The only difference: Oil adds more calories. (Some sardines are packaged in mustard, with lemon or chili peppers, or in tomato sauce, which might add additional calories; check the label.)
How to Cook
Sardines are cheap and versatile. The most adventurous eat them whole—head and all. You can remove the head, scale and gut the fish, then grill or barbecue it as a main dish. Some canned sardines are already scaled and deboned. For a simple meal, clean the sardines and toss with olive oil, salt, and pepper. Bake the fish for 10 to 12 minutes in a 350-degree oven. When done, the sardines will be crispy and perfect as a salad topper. If you’re new to sardines, Hutmacher recommends “hiding” them: Mince the fish and add them to pasta sauce, stews, or three-bean soup. “It’s going to add a really nice depth of flavor to that sauce,” he says.

Brussels Sprouts
You could mistake brussels sprouts for mini heads of cabbage, but the tiny green globes are really a close relative. Pick sprouts that are about an inch thick, bright green, and firm—and skip those that are yellow, squishy, or wilted. Stored in the refrigerator, your sprouts will last a couple of weeks, says Hutmacher. When you’re ready to eat, peel back the first few leaves, which can be wilted or damaged, then soak them in cold water to remove any residue or dirt before cooking.
Why They’re Worth It
Brussels sprouts are low in sodium and cholesterol free. “They are a good source of fiber,” says Salge-Blake. “And we also have some studies to show vegetables in the cruciferous family have phytochemicals [plant compounds that have protective health benefits] in them.”
How to Cook
You may remember the boiled brussels sprouts Mom used to make, but there are tastier ways to enjoy the veggie. Hutmacher loves to roast his sprouts with olive oil. First, boil the brussels sprouts in water for 15 to 20 minutes to soften the hard heads. Then roast them with olive oil and salt and pepper at 350 degrees for 10 to 15 minutes. Roasting and adding fat in the form of olive oil will help cut through the vegetable’s bitterness. Add zip by topping the sprouts with lemon slices before baking. Hutmacher also uses brussels sprouts in place of lettuce to create a nutrient-packed salad. To make your own, chop your raw sprouts into thin strips, then toss them with pomegranate seeds, shaved fennel, toasted pine nuts, crumbled feta cheese, and a vinaigrette dressing made of lemon juice, Dijon mustard, olive oil, and herbs like parsley. If you do opt for boiling, be careful not to overcook; you’ll lose water-soluble vitamins. Salge-Blake’s rule: Cook them with only a small amount of water, until they’re tender—and no longer.
Pumpkin Seeds
If you’ve ever carved a jack-o’-lantern, you’ve most likely baked or toasted pumpkin seeds. But there’s no need to wait till October to enjoy the nutrient-packed seeds. The bagged variety (pick a low-sodium kind, either with or without shells) is just as nutritious as home cooked.
Why They’re Worth It
Pumpkin seeds are a good source of fiber, vitamin K, and iron. Plus, they’re loaded with protein, so they’re the perfect addition to vegetarian dishes. “This could be a good way of having a meatless meal,” says Salge-Blake.
How to Cook
You can snack on a handful of pumpkin seeds between meals—just don’t eat the whole pack at once; a 6-ounce bag can have more than 500 calories, 30 grams of fat, and 90 grams of carbs. Or add them to your morning cereal or oatmeal, as Salge-Blake suggests. Hutmacher uses a Mexican technique to incorporate pumpkin seeds in his meals: Start by toasting the pumpkin seeds. Next, add chicken or vegetable broth, and let the mixture come to a boil. Add thyme, garlic, and sesame seeds to the mix, then blend it all until it’s emulsified. Hutmacher uses this mixture (which is a bit runnier than hummus) as a sauce for fish or poultry.

Kale
The dark green vegetable looks something like lettuce with its ruffled leaves, but, just like brussels sprouts, it’s a member of the cabbage family. Fresh kale is coarse with dark leaves. Avoid bunches that are yellow or brown and have a rubbery texture. Kale will last three to five days in the refrigerator if you store it loosely in a plastic bag. Before you cook the leaves, rinse them and trim off the thick stems. And keep in mind: Two cups of raw kale will cook down to about a cup’s worth.
Why It’s Worth It
Like its cousin broccoli, kale is packed with vitamin C. (Two cups have twice as much vitamin C as a medium orange.) It’s also a good source of vitamin A (beta carotene), calcium, and potassium, which has been shown to lower high blood pressure.
How to Cook
You can eat kale raw, in place of lettuce in a salad, but the classic cooking method is braising. Hutmacher chops his kale into strips (smaller pieces cook faster) and adds it to a pan of turkey bacon sautéed in olive oil with onion, celery, and carrots. To cut the kale’s bitter flavor, he adds lemon juice or cider vinegar to the mix, then steams the kale in the broth. Once the kale has stewed in the covered pan for half an hour (the kale will look dark and wilted), he removes the lid and lets the liquid reduce. That’s when Hutmacher grabs a big serving, spoons sauce over the kale, and digs in. Another option? “I like stir-frying it,” says Salge-Blake. She cooks it in olive oil with garlic and then uses it as a bed for grilled scallops or chicken.

The main reason to add some superfoods to your meals? The nutritional benefit. “There isn’t one perfect vegetable that has everything. There isn’t a perfect food,” says Salge-Blake. “The more variety in your diet, the more chance you’re going to consume all the nutrients your body needs.” And remember, there’s no need to spend half your paycheck on mysterious fruit drinks from South America. The best superfoods can all be found close to home.

By Tracey Neithercott / Recipes by Robyn Webb, MS, LN

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