Effect of Biliopancreatic Diversion on Glucose Homeostasis

Study Overview
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Brief Summary
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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).

Official Title
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Effect of Biliopancreatic Diversion on Glucose Homeostasis

Conditions
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Obesity, Morbid

Intervention / Treatment
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* Procedure: Roux-en-Y Gastric Bypass Surgery
* Procedure: Biliopancreatic Diversion Surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: RYGB<br>Subjects received Roux-en-Y Gastric Bypass surgery. | Procedure: Roux-en-Y Gastric Bypass Surgery<br>* In Roux-en-Y Gastric Bypass Surgery a small gastric pouch is created and connected to a segment of jejunum. Bowel continuity is restored by reconnecting the Roux limb and the biliopancreatic limb approximately  75-150 cm distal to the gastrojejunostomy. Therefore, ingested food bypasses most of the stomach, the entire duodenum, and a short segment of the jejunum.<br>|
| Experimental: BPD<br>Subjects received Biliopancreatic Diversion Surgery | Procedure: Biliopancreatic Diversion Surgery<br>* In Biliopancreatic Diversion Surgery a horizontal gastrectomy is conducted leaving a portion of the stomach, which is connected to the small intestine,  250 cm from the ileocecal valve and the biliopancreatic limb is connected to the ileum,  50 cm from the ileocecal valve. Digestive secretions from the biliopancreatic limb mix in the common channel, where ingested food is also delivered by the alimentary limb.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | Change from Baseline up to a possible 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bariatric Surgery, Roux-en-Y gastric bypass, Biliopancreatic Diversion