• American heart journal · Mar 2006

    Review

    Clinical trial issues in weight-loss therapy.

    • Manesh R Patel, Mark Donahue, Peter W F Wilson, and Robert M Califf.
    • Duke University Medical Center, Durham, NC 27708, USA. patel017@notes.duke.edu
    • Am. Heart J. 2006 Mar 1; 151 (3): 633-42.

    BackgroundOverweight and obesity rates continue to increase nationally, generating significant interest in weight-loss therapies to address both the burden of obesity-associated chronic disease and individual concerns about appearance. Effective obesity therapies also have the potential for off-label use and unintended consequences.MethodsThe behavioral, pharmacologic, and surgical therapies for obesity are reviewed. Clinical trial issues common to chronic disease states and issues specific to obesity trials are examined. Finally, study designs for obesity therapy, including populations, control arms, sample size, and duration of therapy, are discussed.

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