Experimental lipid-lowering drug improves glucose control in diabetic patients

High triglycerides -- a type of fat, or lipid, in the blood -- increase the risk of heart disease and perhaps type 2 diabetes. For the first time, it has been shown that profoundly lowering triglycerides in diabetics improves their insulin sensitivity over time, which helps them maintain healthy glucose - blood sugar -- levels. Volanesorsen, an experimental lipid-lowering medication, improved insulin sensitivity and glucose control by significantly decreasing patients' overall hemoglobin A1c -- the standard clinical measurement of blood glucose levels for diabetics -- in a new study reported by researchers from the Perelman School of Medicine at the University of Pennsylvania. The results are published online this month in Diabetes Care.

Researchers enrolled 15 adult patients with type 2 diabetes and hypertriglyceridemia who had been taking metformin - an oral medication that helps control blood sugar levels - for their diabetes. Patients were randomly assigned to two groups: one to receive volanesorsen and the other a placebo. After taking the medication for 12 weeks, researchers found that patients on volanesorsen experienced a 69 percent reduction in triglycerides, and a 57 percent improvement in whole-body insulin sensitivity. Several tests of glucose control, including hemoglobin A1c, were also significantly improved. Researchers concluded that the drop in triglycerides was strongly related to improved insulin sensitivity and improved hemoglobin A1c.

"These results prove volanesorsen to be an effective treatment method for improving insulin sensitivity, but what's most interesting, and perhaps most encouraging, is that this drug also significantly improved patients' hemoglobin A1c levels," said the study's lead co-author, Richard Dunbar, MD, an assistant professor of Cardiovascular Medicine at Penn. "In most cases, it takes many months of therapy to improve the hemoglobin A1c, so to move the needle so significantly in a fairly short time is very promising. Scientifically, these results provide important proof that profoundly lowering triglycerides improves insulin sensitivity. And clinically, the results go a step further and show that doing so improves the underlying metabolic problems enough to actually improve diabetes."

To quantify the effects of the drug, researchers used a very sophisticated test of insulin sensitivity, the hyperinsulinemic-euglycemic clamp or "the clamp," which is largely regarded as the gold standard in insulin sensitivity measurement. This technique infuses insulin at fixed rates, and infuses glucose at a varying rate to keep blood glucose constant, in order to determine how well a patient responds to insulin.

For many years, researchers had suspected that high triglycerides worsened diabetes, but there had not been powerful tool to prove this concept.

"While we were able to determine the effectiveness of this medication in a very specific group of diabetic patients, it will be important to evaluate this drug in a broader diabetic population," Dunbar said. "The next phase will be to determine clinical success in patients with type 2 diabetes on the whole range of diabetic medications or perhaps with less severe lipid problems. It will also be important to conduct longer studies, as glucose control may improve even further with longer exposures to the drug."

Several other classes of medications that profoundly lower triglycerides are also in development. If improved insulin sensitivity and improved glucose control are truly the result of lowering triglycerides, researchers suggest these other novel drugs should show the same effect.

Dunbar added, "after a long dry spell, there is a lot of activity right now for triglyceride-lowering therapies. Penn Medicine has been conducting several clinical trials evaluating this and other novel triglyceride-lowering drugs. Not only do we have a variety of very potent options emerging, we may be able to help improve glucose at the same time. Both of these developments would be great news for our patients with high triglycerides, including diabetics."

New drug improves glycaemic control with minimum risk of hypoglycemia in type 2 diabetics..

TAK-875, a new treatment for type 2 diabetes, improves blood sugar control and is equally effective as glimepiride, but has a significantly lower risk of creating a dangerous drop in blood sugar, called hypoglycemia, according to a new study. TAK-875 is a novel oral medication designed to enhance insulin secretion in a glucose-dependant manner, which means that it has no effect on insulin secretion when glucose levels are normal, and as such has the potential to improve the control of blood sugar levels without the risk of hypoglycemia.

In the study, Charles Burant, M.D., Ph.D., professor of internal medicine at the University of Michigan Health System, and colleagues randomly assigned 426 patients with type 2 diabetes who were not achieving adequate glucose control through diet, exercise or metformin treatment to one of five doses of TAK-875, a placebo, or glimepiride, a conventional diabetes treatment. The primary outcome was change in hemogloblin A1c from the start of the study.

At 12 weeks, all doses of TAK-875 resulted in significant drops in HbA1c compared with placebo, a similar reduction occurred in patients given glimepiride.

At a TAK-875 dose of 25 mg or higher, about twice as many patients (33 to 48 percent) reached the American Diabetics Association target of HbA1c less than 7 percent within 12 weeks, compared with placebo (19 percent) and was similar to glimepiride (40 percent).

Ref : http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(11)61879-5/fulltext

Cinnamon May Help Ease Common Cause of Infertility, Study Says...

A small study by researchers from Columbia University Medical Center in New York City found that women with polycystic ovary syndrome who took inexpensive daily cinnamon supplements experienced nearly twice the menstrual cycles over a six-month period as women with the syndrome given an inactive placebo. Two of the women in the treated group reported spontaneous pregnancies during the trial.

"There is a lot of interest in homeopathic or natural remedies for this condition," said study author Dr. Daniel Kort, a postdoctoral fellow in reproductive endocrinology at the medical center. "This may be something we can do using a totally natural substance that can help a large group of patients."

The study was scheduled for presentation Wednesday at a meeting of the International Federation of Fertility Societies and American Society for Reproductive Medicine in Boston.

An estimated 5 percent to 10 percent of women of childbearing age have polycystic ovary syndrome, with up to 5 million Americans affected. Polycystic ovary syndrome, which involves many of the body's systems, is thought to be caused by insensitivity to the hormone insulin. Typical symptoms include menstrual irregularity, infertility, acne, excess hair growth on the face or body, and thinning scalp hair.

Treatment for polycystic ovary syndrome currently includes weight loss, ovulation-inducing drugs such as clomiphene (brand name Clomid) and diabetes medications such as metformin, said Dr. Avner Hershlag, chief of the Center for Human Reproduction at North Shore University Hospital in Manhasset, N.Y.

Kort said that it's not yet clear exactly why cinnamon may work to regulate menstrual cycles in those with polycystic ovary syndrome, but it may improve the body's ability to process glucose and insulin. Prior research among diabetic patients suggested the spice can reduce insulin resistance.

Of the 16 patients who completed Kort's trial, 11 were given daily 1,500-milligram cinnamon supplements and five were given placebo pills. Diet and activity levels were monitored, and patients completed monthly menstrual calendars.

After six months, women receiving cinnamon had significant improvement in menstrual cycle regularity, having an average of nearly four menstrual periods over that time compared to an average of 2.2 periods among the placebo group. Two women reported spontaneous pregnancies after three months of cinnamon treatment, meaning they became pregnant without additional help.

Polycystic ovary syndrome "is one of the most common causes why women don't have regular menstrual cycles," Kort said. "But the clinical consequences later in life are truly great from an increased risk of diabetes and glucose intolerance to endometrial cancer. Many women can go their whole lives without regular menstrual cycles, and it doesn't necessarily bother them until they want to have children."

The 1,500-milligram cinnamon dose was chosen for this trial because it was between the 1,000 to 2,000 mg daily that seemed to have metabolic effects on diabetic patients in earlier research, Kort said. But all doses in that range are cheaply obtained, costing pennies per capsule.

"Compared to most medical therapies these days, the cost is very small," he said.

Although the study suggests a link between cinnamon and improvement of polycystic ovary syndrome, it doesn't establish a direct cause-and-effect relationship.

Still, Hershlag called the study "welcome and interesting" and said he sees no reason women with polycystic ovary syndrome shouldn't use more cinnamon in their food or take cinnamon supplements.

"Any work that's something nutritional in nature and seems to affect the abnormal physiology of polycystic ovaries is welcome," Hershlag said. "If they want to spice up their life and take it, that's fine , but I think the best thing to do when you have polycystic ovaries is to be under the control of a physician."

Cinnamon May Help Ease Common Cause of Infertility, Study Says - Drugs.com MedNews

Coffee, Wine Good for Healthy Gut, Sodas May Be Bad

The food you eat and the medicines you take can alter your gut bacteria in ways that either help or harm your health, two new studies suggest.

Foods like fruits, vegetables, coffee, tea, wine, yogurt and buttermilk can increase the diversity of bacteria in a person's intestines. And that diversity can help ward off illness, said Dr. Jingyuan Fu, senior author of one of the studies.

"It is believed that higher diversity and richness [in gut bacteria] is beneficial," explained Fu. She is an associate professor of genetics at the University of Groningen in the Netherlands.

On the other hand, foods containing loads of simple carbohydrates appear to reduce bacterial diversity in the gut, Fu and colleagues found. These include high-fat whole milk and sugar-sweetened soda.

In addition, medications can also play a part in the makeup of your gut bacteria. Antibiotics, the diabetes drug metformin and antacids can cut down on gut bacterial diversity, the researchers found. Smoking and heart attacks also can have a negative effect, the team said.

Each person's intestines contain trillions of microorganisms, which doctors refer to as the "gut microbiome," said Dr. David Johnson. He is chief of gastroenterology at Eastern Virginia Medical School in Norfolk, Va., and a past president of the American College of Gastroenterology.

The gut microbiome plays an essential but little-understood role in human health, said Johnson, who was not involved with the new studies.

"It's the largest immune system in the body," Johnson explained. "These bacteria have a very dramatic and prominent role in determining health and disease."

To study the effect of lifestyle on the gut microbiome, Fu and her colleagues collected stool samples from more than 1,100 people living in the northern Netherlands.

The samples were used to analyze the DNA of the bacteria and other organisms that live in the gut. In addition to stools, the study collected information on the participants' diets, medicine use and health.

In the second study, researchers with the Flemish Gut Flora Project performed a similar analysis on stool samples taken from 5,000 volunteers in Belgium.

Both studies concluded that diet has a profound effect on the diversity of gut bacteria, although, Fu said, the "underlying theories of these dietary factors remain largely unknown."

Johnson added that medicines can have the same effect, and antibiotics actually can kill off some important strains of gut bacteria. "One dose of an antibiotic may disrupt your gut bacteria for a year," he said.

Both sets of researchers emphasized that their studies only help explain a fraction of gut bacteria variation -- roughly 18 percent for the Netherlands study, and about 7 percent for the Flemish study.

However, the findings from the two groups overlapped about 80 percent of the time, indicating that they are on the right track, the researchers said.

The Belgian researchers estimated that over 40,000 human samples will be needed to capture a complete picture of gut bacteria diversity.

Johnson noted that other research has shown that poor sleep, obesity, diabetes and the use of artificial sweeteners also can interfere with gut bacteria.

"The general rule is a balanced diet with high fiber and low carbs tends to drive a better gut health overall," he said.

According to Fu, once researchers have a clearer understanding of the gut microbiome and its effects on health, doctors could be able to help prevent or heal illness by reading or influencing the bacteria within people's bodies.

"The personalized microbiome may assist in personalized nutrition, personalized medicine, disease risk stratification and treatment decision-making," she said.

Both studies were published in the April 29 issue of the journal Science.

Coffee, Wine Good for Healthy Gut, Sodas May Be Bad