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Weight loss achieved through gastric banding will be superior to treatment with metformin in preserving or restoring pancreatic beta cell function in people with prediabetes or mild type 2 diabetes.
BetaFat is a 2-arm, unblinded study to compare gastric banding to treatment with metformin over a 24-month period in moderately obese adults with pre- or mild type 2 diabetes. The primary outcome will be change in β-cell compensation for insulin resistance, which the investigators will compare between groups. Secondary analyses will include other potential markers of β-cell health and potential mediators of treatment-specific effects. The main focus will be on mediators related to obesity. Clinically, the project will serve as a test of concept for use of gastric banding relatively early in the spectrum of obesity and β-cell disease. Biologically, the results will provide crucial information on potential mediators of β-cell failure and its arrest or reversal in the context of obesity. Those mediators will guide the development of more effective treatment and monitoring for the β-cell disease that causes type 2 diabetes.
Age
22 - 65 years
Sex
ALL
Healthy Volunteers
No
University of Southern California
Los Angeles, California, United States
Start Date
June 1, 2013
Primary Completion Date
June 1, 2018
Completion Date
June 1, 2018
Last Updated
October 21, 2019
88
ACTUAL participants
Metformin
DRUG
gastric banding
DEVICE
Lead Sponsor
University of Southern California
Collaborators
NCT01143454
NCT07051005
Data Source & Attribution
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