Effect of Biliopancreatic Diversion on Glucose Homeostasis

Not Applicable

Completed

• Conditions: Obesity, Morbid
• Interventions: Procedure: Biliopancreatic Diversion Surgery; Procedure: Roux-en-Y Gastric Bypass Surgery

• Registration Number: NCT03111953
• Lead Sponsor: Washington University School of Medicine

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-09
• Primary Completion: 2016-06-28
• Study Completion: 2016-06-28
• Study First Submitted: 2017-03-13
• Status Verified: 2017-04
• Study First Submitted QC: 2017-04-07
• Last Update Submitted: 2017-04-07
• Study First Posted: 2017-04-13
• Last Update Posted: 2017-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BPD	Biliopancreatic Diversion Surgery	Subjects received Biliopancreatic Diversion Surgery
RYGB	Roux-en-Y Gastric Bypass Surgery	Subjects received Roux-en-Y Gastric Bypass surgery.

Primary Outcome Measures

Name	Time	Method
Change from baseline in skeletal muscle insulin sensitivity will be assessed using the Hyperinsulinemic-Euglycemic Clamp (HEC) procedure, before and after weight loss induced by either BPD or RYGB surgery	Change from Baseline up to a possible 9 months	Insulin sensitivity: The HEC procedure will be used to evaluate insulin sensitivity before and after 20% weight loss induced by either BPD or RYGB surgery

Trial Locations

Locations (1)

Catholic University of the Sacred Heart; 🇮🇹 Rome, Italy