Physiological Impact of Each Component of the Biliopancreatic Diversion With Duodenal Switch and Sleeve Gastrectomy

Summary

Bariatric surgery procedures promote weight loss by limiting the amount of food consumed through reduction of the size of the stomach and by decreasing absorption of nutrients through reorganizing or bypassing portions of the small intestine. Among the procedures used to induce weight loss, sleeve gastrectomy (SG) was initially developed in the early 90's as the restrictive component of a biliopancreatic diversion with duodenal switch (BPD-DS). It was then offered by laparoscopy as a staged-approach in order to reduce peri-operative complications in high-risk patients. The second step of the surgery (i.e. the duodenal switch) was planned when sufficient weight loss had been obtained. However, it was observed that some patients experienced appreciable weight loss with the SG alone, and did not require a second-stage surgery, thus avoiding the side-effects of a malabsorptive surgery. This led to the surge in popularity of SG as a stand-alone operation, because of its relative technical simplicity, feasibility, and good outcomes. Multiple mechanisms have been postulated to induce metabolic recovery and weight loss following surgery. The independent effects of each component of the BPD-DS with SG have never been investigated in humans within a well-controlled study design. The general objective of the present project is to assess the impact of each component of the BPD-DS and SG, either combined of separated, on physiological variables potentially responsible for metabolic recovery. Patients will be randomized to undergo one of three surgical sequences: 1) SG followed by BPD-DS one year later; 2) BPD-DS followed by SG one year later; or 3) SG and BPD-DS within a single operation. A series of tests will be performed at baseline, at 1 year, and 2 years after the initial surgery. We propose two Specific Aims to asses 1) the impact of each surgical component on the hormonal determinants of metabolic recovery; and 2) the impact of weight loss responses on subcutaneous and visceral adipose tissue function improvements. This project will help better understand the mechanisms underlying metabolic recovery following weight loss surgery.

Conditions

• Biliopancreatic Diversion With Duodenal Switch
• Gastrectomy

Interventions

PROCEDURE

Gastrectomy

PROCEDURE

BPD-DS

Sponsors & Collaborators

• Johnson & Johnson

  collaborator INDUSTRY

• Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

  collaborator OTHER

• Laval University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-01-31

Primary Completion

2017-12-31

Completion

2017-12-31

Countries

• Canada

Study Locations