Feb. 6, 2002 (Washington) -- In a landmark study, either a low-fat diet combined with moderate exercise or the drug metformin -- brand name Glucophage -- dramatically reduced type 2 diabetes risk among overweight people with elevated blood sugar.
The findings are crucial for battling the nation's "surging epidemic" of type 2 diabetes, said Allen Spiegel, MD, director of the National Institute of Diabetes and Digestive and Kidney Diseases at the NIH.
The National Institutes of Health, or NIH, originally released the results of this study last August due to their importance. The study is now published in the Feb. 7 issue of The New England Journal of Medicine.
"For the first time, we know that type 2 diabetes can be prevented," said Christopher Saudek, MD, president of the American Diabetes Association. "It may be as simple a solution as getting up off the couch and eating a healthier diet."
"This really puts prevention on the map," said David Nathan, MD, a Harvard Medical School professor who led the $174-million government-sponsored study.
Indeed, the study found that the diet/exercise program cut diabetes risk by 58%. Glucophage was significantly less effective, but still decreased risk by 31%. Both approaches worked equally well among diverse ethnic and racial groups.
The diet/exercise changes worked especially well among people age 60 and older, whereas Glucophage worked best in younger and heavier individuals.
Type 2 diabetes, which represents the vast majority of diabetes cases, has tripled in frequency over the last 30 years, largely due to a huge explosion in obesity. Since 1960, the percentage of Americans who are obese has roughly tripled.
More than 16 million Americans have diabetes; 8% of all Americans older than 20 have type 2 diabetes. The lifelong disease is the nation's leading cause of kidney failure, blindness, and limb amputations. Blacks and Hispanics suffer an especially high rate of the disease.
According to Spiegel, some 10 million Americans would fit the health profile of the people in this diabetes study. The study's 3,234 participants were significantly overweight. They also had pronounced "impaired glucose tolerance," meaning a high but not yet diabetic blood sugar level.
The average age of people in the study was 51, although ages ranged from 25 to 85. Close to 1,000 of them were put on a low-fat diet and told to engage in moderate physical exercise, such as walking for 30 minutes.
The diet was centered around lowering fat intake to less than 25% of overall calories. But those in the study also got training in goal-setting and problem-solving and were invited to participate in group events.
Spiegel said that the 30-minute daily exercise regime "should be easily achievable" by most nondiabetic overweight Americans with high blood sugar levels.
Not only did making these lifestyle changes reduce their risk of getting diabetes by 58%, but these individuals also lost 5%-7% of their body weight. Scientists believe weight loss can lower diabetes risk by helping muscle cells to more efficiently handle blood sugar.
Another 1,000 or so people took Glucophage, and a third group of 1,000 took placebo pills.
Glucophage is already a highly profitable drug for Bristol Myers Squibb; it was approved by the FDA in 1995 for treating type 2 diabetes. A generic form was approved just last month. The drug does not yet, however, have clearance for use in preventing diabetes. The drug is off-limits for people with kidney or liver problems or for heavy drinkers.
Tommy Thompson, secretary of Health and Human Services, said in August 2001 that the study's results proved that "prevention works." He said his agency would work on recommendations to help put the results into national practice.
Meanwhile, researchers still have numerous unanswered questions. Can diet/exercise or Glucophage prevent diabetes indefinitely? Those in the study have only been followed for three years. "We simply don't know how long, beyond the three-year period studied, diabetes can be delayed," said Nathan.
And could Glucophage and the diet/exercise changes together provide an even greater benefit than either does alone?
"One could speculate that [Glucophage] would be additive, but it may be that once you get to 58% reduction with the lifestyle [changes], you can't do any better than that," Nathan tells WebMD. "It's just unknown. We'd all like to know whether it would make a difference."