The first long-term study to look at the effects of weight loss in people with type II diabetes begins today. UCLA is one of 16 institutions throughout the country identified as a research site.

Funded by the National Institute of Diabetes and Digestive and Kidney Diseases 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 nationwide.

Look AHEAD will examine how these lifestyle interventions affect heart attack, stroke and cardiovascular-related death in people with type II diabetes — the disease most affected by obesity and excess weight. During the clinical trial, this lifestyle intervention program will be compared to a program involving diabetes support and education.

People between the ages of 45 and 75, who have type II 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.

Volunteers 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.

A comparison group will be enrolled in the Diabetes Support and Education Program, an alternative to the lifestyle intervention program. Volunteers 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 II diabetes,” said Dr. Mohammed Saad, principal investigator and professor, Division of Endocrinology, Diabetes and Hypertension. “We know short-term weight loss can benefit overweight people with diabetes; and we hope to gather data about the long-term effects of weight loss in the Look AHEAD study.”

More than 50 percent of adults in America are considered overweight. The percentage of obese Americans has risen from 16 to 22 percent in the last 15 years. Although the reasons are not well understood, excess weight affects minorities disproportionately.

Type II 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 II diabetes are overweight or obese. In addition, type II 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 II diabetes.

“Obesity in America is a serious risk factor for a number of diseases and conditions -- especially diabetes,” Saad said. “This study will help us better understand the effects of weight-loss on diabetes and other related disorders.”

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 federal sponsors of Look AHEAD, all part of the National Institutes of Health, include the National Heart, Lung and Blood Institute; the National Institute of Nursing Research; The National Center on Minority Health and Health Disparities; and the Office of Research on Women’s Health. The Centers for Disease Control and Prevention is also a sponsor.