Recruiting

Surgery vs. Medical Management

Sponsor:

Laval University

Code:

NCT02390973

Conditions

Bariatric Surgery Candidate

Diabetes

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

Sleeve Gastrectomy

Roux-en-Y Gastric Bypass

Biliopancreatic Diversion with Duodenal Switch

Medical management

Study Details

Brief summary:

Bariatric surgery procedures induce weight loss through restriction and/or malabsorption. The mechanisms underlying type 2 diabetes remission and others metabolic improvements after Roux-en-Y Gastric Bypass (RYGB), sleeve gastrectomy (SG) or biliopancreatic diversion with duodenal switch (BPD-DS) have not yet been formally studied. The investigators propose a longitudinal study with the overall objective of measuring the long-term impact of these three bariatric surgeries (RYGB, SG, BPD-DS) on metabolic, renal and cardiovascular fate in patients with type 2 diabetes. The investigators overall hypothesis is that some bariatric procedures generate hitherto unrecognized effects on many disease-related outcomes, which greatly contributes to their beneficial impact in diabetic patients. The investigators propose 3 specific aims: 1) to establish the long term effect of the three surgeries on the metabolic recovery and quality of life in groups of diabetic patients treated with insulin, hypoglycemic agents or diet; 2) to establish the long term impact of the three surgeries on renal and cardiovascular functions in subgroup of patients with these conditions; 3) to compare metabolic impact of surgeries to those of best medical care for diabetes in a non-surgical control group. For most severely obese patients, lifestyle interventions, perhaps effective in inducing short-lived weight losses, are ineffective for long-term weight loss maintenance and durable metabolic recovery. The increasing popularity of obesity surgeries calls for a better understanding of the underlying mechanisms. This is especially true and urgent when considering that knowledge on the relative impact of each procedure (i.e. SG vs. RYGB and BPD-DS) in resolving T2D is still limited. Better knowledge on each of the procedures will allow stronger scientific rationale for selecting the right surgery for the right patient and improve care for the severely obese individual.

Conditions

Bariatric Surgery Candidate

Diabetes

Study ID

NCT02390973

Start date

Mar, 2015

Status verified date

Oct, 2025

Completion date

Mar, 2030

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • BMI ≥ 35
  • type 2 diabetes
  • HbA1c ≥ 6,5 % or fasting glycemia ≥7mmol/l or non-fasting glycemia ≥11mmol/l
  • able to consent

Exclusion Criteria:

  • pregnancy
  • past esophageal, gastric or bariatric surgery
  • irritable bowel, unexplained intermittent vomiting, severe abdominal pain, chronic diarrhea or constipation
  • history of gastric or duodenal ulcers
  • pre-operatory hypoalbuminemy
  • history of renal, hepatic, cardiac or pulmonary severe disease
  • taken of corticosteroid in the last month
  • evidence of psycological problem that may affect the capacity to understand the project and to comply with the medical recommandations
  • history of drug use or alcool abuse in the last 12 months
  • history of gastro-intestinal inflammatory diseases

Study Design

Enrollment

408 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Sleeve gastrectomy

active comparator: Roux-en-Y Gastric Bypass

active comparator: Biliopancreatic Diversion

active comparator: Control

the best medical management of their diabetes, non-surgical group

Interventions

Sleeve Gastrectomy

Roux-en-Y Gastric Bypass

Biliopancreatic Diversion with Duodenal Switch

Medical management

Primary outcome measure

  • Type 2 diabetes remission rate [ Time Frame: from baseline up to 60 months ]

Central Contacts and Locations

Central contacts

Locations

Institut Universitaire de Cardiologie et de Pneumologie de Québec

Recruiting

Québec, Quebec, Canada, G1V 4G5

Contacts

Principal Investigator:

Laurent Biertho, MD

More Information

Sponsor

Laval University

Last update posted

Dec 8, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Laval University on 2025-12-08.