BOSTON (January 22, 2002) — More than 40 men and women from the Boston area – ranging from nurses to accountants to retirees – have already put their New Year’s resolutions to lose weight and exercise more to the ultimate test by enrolling in the first long-term study to look at the effects of weight loss in people with type 2 diabetes in a nationwide study conducted locally at Massachusetts General Hospital, Joslin Diabetes Center and Beth Israel-Deaconess Medical Center. The three institutions, which jointly make up one of the study’s 16 research sites in the United States, are seeking to enroll a total of 313 volunteers for the study over the next two years.
Funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health (NIH), it is the largest study on the effects of weight-loss interventions ever funded by the NIH. The study began screening participants for eligibility in July.
Named Look AHEAD: Action for Health in Diabetes, the multicenter, randomized clinical trial will examine the effects of a lifestyle intervention program designed to promote weight loss through reduced calorie intake and regular exercise in approximately 5,000 volunteers. Look AHEAD will examine how the lifestyle interventions affect heart attack, stroke and cardiovascular-related death in people with type 2 diabetes—the disease most affected by excess weight. An intensive lifestyle intervention program will be compared to a program involving general diabetes support and education.
People who are between 45 and 75 years of age, have type 2 diabetes and are classified as overweight or obese (body mass index equal to or greater than 25 kg/m2) are eligible for the study. The study seeks equal numbers of men and women and expects that 33 percent of the participants will come from ethnic minority groups.
People who qualify for Look AHEAD will be assigned at random to either its Lifestyle Program or its Diabetes Support and Education Program. The Lifestyle Program is an intensive diet and exercise program designed to help participants lose at least 10 percent of their initial weight in the first year of the study. Participants are expected to adopt a program of regular exercise, primarily walking, with a goal of 25 minutes per day. The comparison group enrolled in the Diabetes Support and Education Program will attend sessions on nutrition and physical activity and may attend support groups with other people who have diabetes.
Individuals will be followed for up to 11.5 years. Researchers will track cardiovascular risk factors, diabetes control and development of complications, general health and quality of life.
“We have an enormous opportunity to learn more about the role long-term weight loss can play in improving the health of overweight individuals with type 2 diabetes,” said David M. Nathan, M.D., local principal investigator of Look AHEAD and director of the Diabetes Center at Massachusetts General Hospital. “We know that short-term weight loss can benefit overweight people with diabetes; and we now know, thanks to the Diabetes Prevention Program, that weight loss can prevent type 2 diabetes. In Look AHEAD, we hope to learn whether it can also improve the long-term health – especially cardiovascular health – of overweight people who have diabetes.” Dr. Nathan is Professor of Medicine at Harvard Medical School. The Diabetes Prevention Program, a major national study, announced last year that lifestyle changes can reduce the chance that at-risk adults will develop type 2 diabetes.
More than 50 percent of adults in America are considered overweight. The percent of obese Americans has risen from 16 to 22 percent in the past 15 years. Although the reasons are not well understood, obesity affects minorities disproportionately.
Type 2 diabetes has reached epidemic proportions in the United States, largely due to the number of Americans who are overweight. According to the American Diabetes Association, the incidence of diabetes among people 40 to 74 years of age increased 38 percent between 1976 and 1994. Today, 80 percent of people with type 2 diabetes are overweight.
“This study will provide vital information on how losing weight and exercising regularly impacts the cardiovascular health of those with type 2 diabetes. We know that type 2 diabetes is associated with a two-to-fourfold increased risk of coronary artery disease. Heart attacks and strokes are the leading causes of death in people with type 2 diabetes,” said Edward S. Horton, MD, Look AHEAD co-investigator, and director of Clinical Research at Joslin Diabetes Center, who is directing the Joslin-BIDMC part of the study. Dr. Horton is Professor of Medicine at Harvard Medical School.
“Obesity in America is a serious risk factor for a number of diseases and conditions, diabetes especially,” said George Blackburn, M.D., Ph.D., an obesity expert at Beth Israel Deaconess Medical Center and the S. Daniel Abraham Associate Professor of Nutrition at Harvard Medical School.
Short-term weight loss has been shown to have beneficial effects on diabetes and cardiovascular disease. To date there have been no randomized trials on the long-term benefits of weight loss because of the difficulty of achieving and maintaining weight loss. The study has a budget of more than $180 million.
Other sponsors of Look AHEAD include the National Heart, Lung and Blood Institute; the National Institute of Nursing Research; The National Center for Minority Health and Health Disparities; the Office of Research on Women’s Health; all of the NIH, and the Centers for Disease Control and Prevention.
People in the Boston area who meet the study criteria and wish to participate in the study should call toll-free at (866) 223-8644. Additional information about the study is available at www.LookAHEADstudy.org.
For more information, contact:
Nicole Gustin, MGH, (617) 724-6425,
ngustin@partners.org
Marge Dwyer, Joslin, (617) 732-2415,
marjorie.dwyer@joslin.harvard.edu
Jerry Berger, BIDMC, (617) 632-8062,
mailto:jberger@caregroup.harvard.edu