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"Cardiovascular Effects of Intensive Lifestyle Intervention in Type 2 Diabetes.

Weight loss is recommended for overweight or obese patients with type 2 diabetes. This recommendation is based on short-term studies showing numerous benefits of weight loss, including improvements in glycemic control, risk factors for cardiovascular disease, quality of life, and other obesity-related coexisting illnesses."

"Cardiovascular Effects of Intensive Lifestyle Intervention in Type 2 Diabetes" source

"However, it is unknown whether weight loss reduces the risk of cardiovascular morbidity and mortality in patients with type 2 diabetes. Epidemiologic studies involving patients with diabetes have had conflicting results, perhaps because of confounding from unintentional weight loss. A meta-analysis of cohort studies concluded that moderate intentional weight loss was associated with reduced mortality among patients who were classified as “unhealthy,” including those with diabetes. The Swedish Obese Subjects (SOS) study showed reduced rates of cardiovascular events during a mean follow-up of 13.3 years among patients with type 2 diabetes who had undergone bariatric surgery. However, the study was not randomized, and the results achieved through surgery cannot be generalized to other methods of weight loss.

Thus, a critical question remains: Would an intensive lifestyle intervention designed to achieve weight loss through caloric restriction and increased physical activity decrease cardiovascular morbidity and mortality among overweight or obese adults with type 2 diabetes? The Look AHEAD (Action for Health in Diabetes) researchers addressed this question in a multicenter, randomized clinical trial.

METHODS

Study Design

The study methods have been published previously. The study was conducted at 16 clinical sites in the United States (for details, see the Supplementary Appendix, available with the full text of this article at NEJM.org). It was designed and conducted by the authors, and all analyses were completed by the coordinating center. The study was approved by the institutional review board at each center. The trial was not blinded, but clinical assessors and end-point adjudicators were unaware of study-group assignments. The authors vouch for the accuracy and completeness of the data and all analyses and for the fidelity of this report to the trial protocol, available at NEJM.org.

The study was sponsored by the National Institutes of Health, with additional support from other federal partners and the clinical research centers of several participating institutions. None of the corporate supporters, listed below, had any role in the trial design, data analysis, or reporting of results."

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