Landmark NIH Study: Diet And Exercise Dramatically Delay Type 2 Diabetes
INDIANAPOLIS - At least 10 million Americans at high risk for type 2 diabetes can sharply lower their chances of getting the disease with diet and exercise, according to the findings of a major clinical trial conducted by the Indiana University School of Medicine and 26 other medical centers nationwide.
The results of the five-year study were announced Wednesday, Aug. 8, in Washington, D.C., by Health and Human Services Secretary Tommy G. Thompson. The National Institutes of Health clinical trial was ended early because of the conclusive results.
"In view of the rapidly rising rates of obesity and diabetes in America, this good news couldn't come at a better time," said Thompson. "So many of our health problems can be avoided through diet, exercise and making sure we take care of ourselves. By promoting healthy lifestyles, we can improve the quality of life for all Americans and reduce health care costs dramatically.
The same study found that treatment with the oral diabetes drug metformin (Glucophage®) also reduces diabetes risk, though less dramatically, in people at high risk for type 2 diabetes.
"This is the largest clinical trial ever conducted by the National Institutes of Health and it will have profound public health implications," said David G. Marrero, Ph.D., professor of medicine and principal investigator of the IU School of Medicine trial. "This trial shows that type 2 diabetes can be prevented or delayed and will emphasize a shift to prevention in diabetic care."
Dr. Marrero also was active on the national level, serving as one of about a dozen researchers who designed the study. He also is chairman of the committee translating the national findings.
Participants randomly assigned to intensive lifestyle interventions reduced their risk of getting type 2 diabetes by 58 percent. On average, this group maintained their physical activity at 30 minutes per day, usually with walking or other moderate exercise, and lost 5 percent to 7 percent of their body weight.
Participants randomized to treatment with metformin reduced their risk of getting type 2 diabetes by 31 percent.
"Every year a person can live free of diabetes means an added year of life free of the suffering, disability, and the medical costs incurred by this disease," said Dr. Marrero. "The Diabetes Prevention Program findings represent a major step toward the goal of containing and ultimately reversing the epidemic of type 2 diabetes in this country. We are very grateful to the 192 Hoosiers who participated in the study at IU."
The findings came from the Diabetes Prevention Program, a major clinical trial comparing diet and exercise to treatment with metformin in 3,234 people with impaired gludose tolerance, a condition that often precedes diabetes. On the advice of the DPP's external data monitoring board, the trial ended a year early because the data had clearly answer the main research questions.
Smaller studies in China and Finland have shown that diet and exercise can delay type 2 diabetes in at-risk people, but the DPP is the first major trial to show that diet and exercise can effectively delay diabetes in a diverse American population of overweight people with impaired glucose tolerance. IGT is a condition in which blood glucose levels are higher than normal but not yet diabetic.
Forty-five percent of the participants enrolled in the DPP were from minority groups that suffer disproportionately from type 2 diabetes: African Americans, Hispanic Americans, Asian Americans and Pacific Islanders, and American Indians. The trial also recruited other groups known to be at higher risk for type 2 diabetes, including individuals age 60 and older, women with a history of gestational diabetes, and people with a first-degree relative with type 2 diabetes.
Lifestyle intervention worked as well in men and women and in all the ethnic groups, as well as those age 60 and over, who have a nearly 20 percent prevalence of diabetes. Metformin also was effective in men and women and in all the ethnic groups, but was relatively ineffective in the older volunteers and in those who were less overweight.
DPP volunteers were randomly assigned to one of the following groups:
· intensive lifestyle changes with the arm of reducing weight by 7 percent
through a low-fat diet and exercising for 150 minutes a week.
· treatment with the drug metformin (850 mg twice a day), approved in
1995 to treat type 2 diabetes.
· a standard group taking placebo pills in place of metformin.
The latter two groups also received information on diet and exercise.
A fourth arm of the study, treatment with the drug troglitazone combined with standard diet and exercise recommendations, was discontinued in June 1998 due to the potential for liver toxicity.
DPP participants ranged in age from 25 to 85, with an average age of 51. Upon entry to the study, all had impaired glucose tolerance as measured by an oral glucose tolerance test, and all were overweight, with an average body mass index of 34.
About 29 percent of the DPP standard group developed diabetes during the average follow-up period of 3 years. In contrast, 14 percent of the diet and exercise arm and 22 percent of the metformin arm developed diabetes. Volunteers in the diet and exercise arm achieved the study goal, on average a 7 percent - 15 pound - weight loss, in the first year and generally sustained a 5 percent total loss for the study's duration. Participants in the lifestyle intervention arm received training in diet, exercise (most chose walking) and behavior modification skills.
Whether the interventions prevent diabetes altogether is unknown. Researchers intend to follow the DPP population beyond the 3-year period of the study to learn how long the interventions are effective. The researchers will analyze the data to determine whether the interventions reduced cardiovascular disease and atherosclerosis, major causes of death in people with type 2 diabetes.
Diabetes afflicts more than 16 million people in the United States. It is the main cause of kidney failure, limb amputations, new onset blindness in adults and a major cause of heart disease and stroke.
Type 2 diabetes, which accounts for nearly 95 percent of all diabetes cases, is most common in adults over the age of 40. It also affects 8 percent of the U.S. population age 20 and older. Risk factors include obesity, inactivity, family history of diabetes and racial or ethnic background. African American adults have a 60 percent higher rate of type 2 diabetes and Hispanic adults have a 90 percent higher rate.
The prevalence of type 2 diabetes has tripled in the past 30 years and much of the increase is due to the dramatic upsurge in obesity. People with a BMI of 30 or greater have a five-fold greater risk of diabetes than people with a normal BMI of 25 or less.
To date, the cost of the DPP trial is $174.3 million. It was funded by the National Institute of Diabetes and Digestive and Kidney Diseases, the National Institute of Child Health and Human Development, the National Institute on Aging, the National Center on Minority Health and Health Disparities, the National Center for Research Resources, the Office of Research on Women's Health and the Office of Behavioral and Social Science Research within the NIH.
Additional funding and support was provided by the Centers for Disease Control and Prevention, the Indian Health Service and the American Diabetes Association. The study also is funded in part through a Cooperative Research Development Agreement with Bristol Myers Squibb with other sources of corporate support from Merck and Company, Merck Medco, Hoechst Marion Roussell, Lifescan, Slim·Fast, Nike and Health-O-Meter.
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Media Contact: Mary Hardin
Tel: (317)274-7722
Email: mhardin@iupui.edu
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