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

Recruiting in Palo Alto (17 mi)

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Laval University

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Eligibility Criteria

Inclusion Criteria

Men and Women between 18-60 years old;

BMI ≥ 45 à ≤ 55 kg/m2;

Subjects capable of understanding and being able to sign a consent form;

Treatment Details

Interventions

• Biliopancreatic Diversion with Duodenal Switch (Procedure)
• Sleeve Gastrectomy (Procedure)

Participant Groups

Group I: BPD-DS Active Control 2 Interventions

Subjects in this group will undergo a BPD-DS as their first surgery with a gastrectomy 1-year later.

Group II: Gastrectomy Active Control 2 Interventions

Subjects in this group will undergo a gastrectomy as their first surgery with a BPD-DS 1-year later.

Group III: Gastrectomy+BPD-DS Active Control 2 Interventions

Subjects in this group will undergo a gastrectomy AND a BPD-DS concomitantly. They will then be closely monitored for the remainder of the study.

Biliopancreatic Diversion with Duodenal Switch is already approved in Canada for the following indications:

Approved in Canada as BPD-DS for:

• Severe obesity
• Type 2 diabetes

Who Is Running the Clinical Trial?

Laval University

Lead Sponsor

Trials

439

Recruited

178,000+

Dr. Pedro O de Campos-Lima

Laval University

Chief Medical Officer since 1998

MD from Federal University of Juiz de Fora, PhD in Tumor Biology from Karolinska Institute

Dr. Manuel Caruso

Laval University

Chief Executive Officer since 1998

PhD in Virology from Pierre and Marie Curie University

Johnson & Johnson

Industry Sponsor

Trials

116

Recruited

167,000+

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

Collaborator

Trials

37

Recruited

9,700+