Clinical trial issues in weight-loss therapy.
BACKGROUND
Overweight 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.


METHODS
The 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.
Patel
Manesh R
MR
Duke University Medical Center, Durham, NC 27708, USA. patel017@notes.duke.edu
Donahue
Mark
M
Wilson
Peter W F
PW
Califf
Robert M
RM
D019440:Anti-Obesity Agents / Q000627:therapeutic use; D001521:Behavior Therapy; D002318:Cardiovascular Diseases / Q000453:epidemiology; D002986:Clinical Trials as Topic; D015897:Comorbidity; D003503:Cyclobutanes / Q000627:therapeutic use; D003920:Diabetes Mellitus / Q000453:epidemiology; D006801:Humans; D008019:Life Style; D009765:Obesity / Q000188:drug therapy / Q000453:epidemiology / Q000628:therapy*; D011379:Prognosis
D019440:Anti-Obesity Agents; D003503:Cyclobutanes; C058254:sibutramine