The first long-term study to look at the effects of weight loss in people with type 2 diabetes was launched at the annual meeting of the American Diabetes Association today. 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.
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 overweight and obesity. This program will be compared to a program involving diabetes support and education.
�More than 16 million Americans have diabetes, with some 800,000 new cases diagnosed each year. If these dangerous trends continue, the impact on our nation�s health and medical care costs in future years will be overwhelming,� said Health and Human Services Secretary Tommy G. Thompson. �This study offers an important opportunity to gain additional insight into effective ways to prevent or reduce the health burden of diabetes.�
People who are between 45 and 75 years of age, have type 2 diabetes and are classified as overweight or obese (as defined by the study protocol) are eligible. 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 meet these criteria and who wish to participate in the study should call (866) 55AHEAD (552-4323) or visit www.LookAHEADstudy.org, the study web site.
Those 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 7 to 10 percent of their initial weight in the first year of the study. Participants will be expected to adopt a program of regular exercise, primarily walking, with a goal of 25 minutes per day. Instead of the lifestyle program, a comparison group will be enrolled in the Diabetes Support and Education Program. They 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. During this period, researchers will track cardiovascular risk factors, diabetes control, the development of complications, and 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 Rena R.Wing, Ph.D., co-chair of Look AHEAD. �We know short-term weight loss can benefit overweight people with diabetes; we just don�t have good data about the long-term effects.�
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, overweight affects minorities disproportionately.
Type 2 diabetes has reached epidemic proportions in the United States, largely due to the number of Americans who are overweight or obese. According to the American Diabetes Association, the incidence of diabetes among middle-aged 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 or obese. In addition, type 2 diabetes is associated with a two- to fourfold risk of coronary artery disease. Heart attacks and strokes are the leading causes of death in people with type 2 diabetes.
�Obesity in America is a serious risk factor for a number of diseases and conditions, diabetes especially,� said F. Xavier Pi-Sunyer, M.D., co-chair of Look AHEAD. �This study will help us understand the effects of weight loss on diabetes and many other disorders.�
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 benefits of long-term weight loss because of the difficulty of achieving and maintaining weight loss. The study has a budget of more than $180 million.
Wing is professor of psychiatry and human behavior at Brown MedicalSchool/Miriam Hospital, and director of their Weight Control and Diabetes Research Center. She also maintains an appointment as professor of psychiatry, psychology and epidemiology at the University of Pittsburgh. She serves on the National Task Force on Prevention and Treatment of Obesity (under the NIDDK), and is an NIDDK Advisory Council member. Pi-Sunyer is director of the Obesity Research Center at St. Luke�s-Roosevelt Hospital Center in New York, and director of the NIDDK-funded New York Obesity and Nutrition Research Center.
Other federal 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.
Source: NIH
