BPD-Mingrone: Effect of Biliopancreatic Diversion on Glucose Homeostasis

Sponsor

Washington University School of Medicine (Other)

Overall Status

Completed

CT.gov ID

NCT03111953

Collaborator

Catholic University of the Sacred Heart (Other), The Foundation for Barnes-Jewish Hospital (Other)

Enrollment

Location

Arms

29.6

Actual Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Obesity, Morbid	Procedure: Roux-en-Y Gastric Bypass Surgery Procedure: Biliopancreatic Diversion Surgery	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Effect of Biliopancreatic Diversion on Glucose Homeostasis

Actual Study Start Date :

Jan 9, 2014

Actual Primary Completion Date :

Jun 28, 2016

Actual Study Completion Date :

Jun 28, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: RYGB Subjects received Roux-en-Y Gastric Bypass surgery.	Procedure: Roux-en-Y Gastric Bypass Surgery 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.
Experimental: BPD Subjects received Biliopancreatic Diversion Surgery	Procedure: Biliopancreatic Diversion Surgery 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.

Arm

Intervention/Treatment

Active Comparator: RYGB

Subjects received Roux-en-Y Gastric Bypass surgery.

Procedure: Roux-en-Y Gastric Bypass Surgery

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.

Experimental: BPD

Subjects received Biliopancreatic Diversion Surgery

Procedure: Biliopancreatic Diversion Surgery

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Catholic University of the Sacred Heart	Rome		Italy	00128

Sponsors and Collaborators

Washington University School of Medicine
Catholic University of the Sacred Heart
The Foundation for Barnes-Jewish Hospital

Investigators

Principal Investigator: Samuel Klein, MD, Washington University School of Medicine
Principal Investigator: Geltrude Mingrone, MD, PhD, Catholic University of the Sacred Heart

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Washington University School of Medicine

ClinicalTrials.gov Identifier:

NCT03111953

Other Study ID Numbers:

411/14

First Posted:

Apr 13, 2017

Last Update Posted:

Apr 13, 2017

Last Verified:

Apr 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Washington University School of Medicine

Bariatric Surgery

Roux-en-Y gastric bypass

Biliopancreatic Diversion

Additional relevant MeSH terms:

Obesity, Morbid

Study Results

No Results Posted as of Apr 13, 2017