Surgery Versus Best Medical Management for the Long Term Remission of Type 2 Diabetes and Related Diseases (REMISSION) (REMISSION)

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetes; Bariatric Surgery Candidate
• Intervention / Treatment: Procedure: Roux-en-Y Gastric Bypass; Procedure: Sleeve Gastrectomy; Procedure: Biliopancreatic Diversion with Duodenal Switch; Other: Medical management

• Study Type: Interventional
• Enrollment (Estimated): 408
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Melanie Nadeau, MSc; Phone Number: 3490 418-656-8711; Email: melanie.nadeau@criucpq.ulaval.ca

Study Locations

• Canada
  • Quebec
    • Québec, Quebec, Canada, G1V 4G5
      • Recruiting
      • Institut Universitaire de cardiologie et de pneumologie de Quebec
      • Principal Investigator: Laurent Biertho, MD
      • Contact: Melanie Nadeau, MSc; Phone Number: 3490 418-565-8711; Email: melanie.nadeau@criucpq.ulaval.ca
      • Contact: Suzy Laroche; Phone Number: 4810 418-656-8711; Email: suzy_laroche@ssss.gouv.qc.ca
      • Principal Investigator: Andre Tchernof, PhD
      • Sub-Investigator: François Dube, MD
      • Sub-Investigator: Paul Poirier, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Sleeve gastrectomy	Procedure: Sleeve Gastrectomy
Active Comparator: Roux-en-Y Gastric Bypass	Procedure: Roux-en-Y Gastric Bypass
Active Comparator: Biliopancreatic Diversion	Procedure: Biliopancreatic Diversion with Duodenal Switch
Active Comparator: Control; the best medical management of their diabetes, non-surgical group	Other: Medical management

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Type 2 diabetes remission rate	percent of patient achieving type 2 diabetes remission in each groups	from baseline up to 60 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in microalbuminuria	Normalisation of A/C ratio after surgery	from baseline up to 60 months
Change in retinopathy		from baseline up to 60 months
Hypertension remission rate	percent of patient achieving hypertension remission in each groups	from baseline up yo 60 months
GERD remission rate	percent of patient achieving gastro-esophageal reflux disease resolution in each groups	from baseline up to 60 months
Quality of life	quality of life after surgery eveluated with questionnaires	from baseline up to 60 months
Sleep apnea remission rate	percent of patient achieving sleep apnea remission in each groups	from baseline up to 60 months
weight loss	weight loss (kg)	from baseline up to 60 months
Regression of liver disease	regression of liver disease documented by percutaneous liver biopsy after surgery	from baseline up to 60 months
Dislipidemia remission	percent of patient achieving dislipidemia remission in each groups	from baseline up to 60 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
short-term complications	comparaison of intra-operative, post-operative and in-hospital complications between groups using clavien classification	baseline up to 4 month
Long-term complications	Vital status and long-term complications including cardiovascular events, micro- or macro-vascular complications, cancer, psychiatric events, bone fractures, operations, readmission related or unrelated to the surgery, changes in medical treatment will be compared between groups	baseline up to 60 months

Collaborators and Investigators

• Sponsor: Laval University
• Collaborators: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval; Johnson & Johnson Medical Products

Publications and helpful links

General Publications

• Bouchard-Mercier A, de Toro-Martin J, Nadeau M, Lescelleur O, Lebel S, Richard D, Biertho L, Tchernof A, Vohl MC. Molecular remodeling of adipose tissue is associated with metabolic recovery after weight loss surgery. J Transl Med. 2022 Jun 23;20(1):283. doi: 10.1186/s12967-022-03485-6.
• Carreau AM, Noll C, Blondin DP, Frisch F, Nadeau M, Pelletier M, Phoenix S, Cunnane SC, Guerin B, Turcotte EE, Lebel S, Biertho L, Tchernof A, Carpentier AC. Bariatric Surgery Rapidly Decreases Cardiac Dietary Fatty Acid Partitioning and Hepatic Insulin Resistance Through Increased Intra-abdominal Adipose Tissue Storage and Reduced Spillover in Type 2 Diabetes. Diabetes. 2020 Apr;69(4):567-577. doi: 10.2337/db19-0773. Epub 2020 Jan 8.

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2030

Study Registration Dates

• First Submitted: February 16, 2015
• First Submitted That Met QC Criteria: March 11, 2015
• First Posted (Estimated): March 18, 2015

Study Record Updates

• Last Update Posted (Actual): December 8, 2025
• Last Update Submitted That Met QC Criteria: December 1, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Nutritional and Metabolic Diseases; Diabetes Mellitus; Professional Practice; Organization and Administration; Health Services Administration; Therapeutics; Surgical Procedures, Operative; Digestive System Surgical Procedures; Anastomosis, Surgical; Biliary Tract Surgical Procedures; Bariatric Surgery; Bariatrics; Obesity Management; Gastroenterostomy; Practice Management; Gastric Bypass; Practice Management, Medical; Biliopancreatic Diversion
• Other Study ID Numbers: Remission