Effect of Biliopancreatic Diversion on Glucose Homeostasis

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).

Conditions

• Obesity, Morbid

Interventions

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.

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.

Sponsors & Collaborators

• Catholic University of the Sacred Heart

  collaborator OTHER

• The Foundation for Barnes-Jewish Hospital

  collaborator OTHER

• Washington University School of Medicine

  lead OTHER

Principal Investigators

• Samuel Klein, MD · Washington University School of Medicine

• Geltrude Mingrone, MD, PhD · Catholic University of the Sacred Heart

Study Design

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2014-01-09

Primary Completion

2016-06-28

Completion

2016-06-28

Countries

• Italy

Study Locations