Effect of Biliopancreatic Diversion on Glucose Homeostasis (BPD-Mingrone)

April 7, 2017 updated by: Washington University School of Medicine
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00128
        • Catholic University of the Sacred Heart

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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
Time Frame: 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
Change from Baseline up to a possible 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Collaborators

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

Investigators

  • Principal Investigator: Geltrude Mingrone, MD, PhD, Catholic University of the Sacred Heart

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 9, 2014

Primary Completion (Actual)

June 28, 2016

Study Completion (Actual)

June 28, 2016

Study Registration Dates

First Submitted

March 13, 2017

First Submitted That Met QC Criteria

April 7, 2017

First Posted (Actual)

April 13, 2017

Study Record Updates

Last Update Posted (Actual)

April 13, 2017

Last Update Submitted That Met QC Criteria

April 7, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 411/14

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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