Effect of Biliopancreatic Diversion on Glucose Homeostasis (BPD-Mingrone)
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About
Biliopancreatic diversion (BPD) surgery results in greater resolution of type 2 diabetes than all other bariatric surgical procedures, and it is hypothesized that this procedure has specific beneficial effects on glucose homeostasis beyond weight loss alone. The BPD procedure is performed in more than 150 patients/year by surgeons at the Division of Obesity and Metabolic Disorders, Catholic University of the Sacred Heart, School of Medicine, in Rome, Italy. The purpose of this study is to provide a better understanding of the effect of the BPD bariatric surgical procedure on insulin action and pancreatic beta cell function. It is hypothesized that weight loss achieved with BPD surgery will have greater effects on insulin sensitivity and beta cell function than weight loss induced by Roux-en-Y gastric bypass (RYGB).
Enrollment
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Volunteers
Inclusion criteria
- Body Mass Index (BMI) ≥ 35 kg/m²
- Undergoing either the RYGB or the BPD procedure.
- Able to provide informed consent to participate in the research study
Exclusion criteria
- Weight > 450 pounds
- Smoke > 7 cigarettes per day
- Previous malabsorptive or restrictive intestinal surgery
- Pregnant or breastfeeding
- Inflammatory intestinal disease
- Diabetes
- Unstable dose of medications in the last 4 weeks before the pre-surgery metabolic studies
- Severe organ dysfunction
Trial design
Primary purpose
Allocation
Interventional model
Masking
24 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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