← Back to Search

Procedure

BPD-DS for Biliopancreatic Diversion with Duodenal Switch

N/A
Waitlist Available
Research Sponsored by Laval University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 12, 24 months
Awards & highlights

Study 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.

Eligible Conditions
  • Biliopancreatic Diversion with Duodenal Switch
  • Gastric Resection

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 12, 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 12, 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Measure the changes in Satiety Levels and the changes in Incretin Levels
Measure the changes of adipose tissue cells sizes and macrophage infiltration

Trial Design

3Treatment groups
Active Control
Group I: BPD-DSActive Control2 Interventions
Subjects in this group will undergo a BPD-DS as their first surgery with a gastrectomy 1-year later.
Group II: GastrectomyActive Control2 Interventions
Subjects in this group will undergo a gastrectomy as their first surgery with a BPD-DS 1-year later.
Group III: Gastrectomy+BPD-DSActive Control2 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.

Find a Location

Who is running the clinical trial?

Laval UniversityLead Sponsor
417 Previous Clinical Trials
172,227 Total Patients Enrolled
Johnson & JohnsonIndustry Sponsor
105 Previous Clinical Trials
26,364 Total Patients Enrolled
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de QuebecOTHER
36 Previous Clinical Trials
9,697 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~4 spots leftby Apr 2025