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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.
Full description
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.
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Inclusion criteria
Exclusion criteria
Contraindications to LapBand(see Appendix 1)
Contraindication to MRI (claustrophobia; permanent metal objects such as pacemakers, prostheses, aneurysm clips)
Underlying disease(s) likely to (a) limit life span to less than study duration and/or (b) increase risk of intervention outside of the study and/or (c) limit ability to participate in outcomes assessment and/or (d) limit participation
An underlying disease known to have important effects on glucose metabolism
Active infections
Renal disease (serum creatinine ≥1.4 mg/dl for men; ≥1.3 mg/dl for women) or serum potassium abnormality (<3.4 or >5.5 mmol/l)
Anemia (hemoglobin <11g/dl in women, <12 g/dl in men) or known coagulopathy
Cardiovascular disease, including uncontrolled hypertension and symptomatic congestive heart failure. Participants must be able to safely tolerate administration of fluid/volume challenges during clamp studies.
Serum AST >3 times upper limit of normal in local clinical lab
Excessive alcohol intake
Suboptimally treated thyroid disease
Conditions or behaviors likely to affect the conduct of the study
additional conditions may serve as criteria for exclusion at the discretion of the local site
Primary purpose
Allocation
Interventional model
Masking
88 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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