This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Overweight and obesity are major health problems in the United States, affecting more than 50% of adults, with 22.5% classified as obese (body mass index > 30 kg/m2). Nowhere is the long-term risk of obesity more manifest than in its effect on Type 2 diabetes. Similarly, CVD is associated with obesity, mediated in part by the two- to four-fold increased risk for CVD associated with Type 2 diabetes. Although short-term weight loss ameliorates obesity-related metabolic abnormalities and CVD risk factors, few, if any, studies have examined the long-term consequences of intentional weight loss in overweight or obese populations. This study will focus on one of the diseases most affected by overweight and obesity, Type 2 diabetes, and on the outcome that causes the greatest morbidity and mortality, cardiovascular disease.
The specific aim of Look AHEAD (Action for Health in Diabetes) is to examine, in overweight volunteers with Type 2 diabetes the long-term effects of an intensive weight loss intervention program designed to achieve and maintain weight loss by decreased caloric intake and increased physical activity. This program is compared to a control condition involving a program of diabetes education and support. The primary basis for the comparison is the incidence of serious cardiovascular events. Other outcomes, including CVD risk factors, diabetes related metabolic factors and complications, and the cost-effectiveness of the intensive intervention are also studied. Approximately 5,000 volunteers with Type 2 diabetes who are 45-75 years of age and overweight or obese (body mass index > 25 kg/m2) will be recruited The primary outcome is the aggregate occurrence of severe CVD events including fatal and non-fatal myocardial infarctions and strokes and CVD deaths over a planned follow-up period of up to 11.5 years. The study is a two-armed randomized, controlled clinical trial. With 5,000 participants, the study has 90% power to detect an 18% difference in major CVD events between the two intervention groups. Specific to this GCRC application, the study will also examine mechanisms through which weight loss and physical activity may influence health. The GCRC will be used to perform exercise testing to evaluate cardiovascular endurance fitness and exercise ECG responses. The Exercise Core Lab was utilized for this protocol.
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