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

NCT ID: NCT02390973

Last Updated: 2025-12-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 408 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2030-03-31

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 Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sleeve gastrectomy

Group Type: ACTIVE_COMPARATOR

Sleeve Gastrectomy

Intervention Type: PROCEDURE

Roux-en-Y Gastric Bypass

Group Type: ACTIVE_COMPARATOR

Roux-en-Y Gastric Bypass

Intervention Type: PROCEDURE

Biliopancreatic Diversion

Group Type: ACTIVE_COMPARATOR

Biliopancreatic Diversion with Duodenal Switch

Intervention Type: PROCEDURE

Control

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

Group Type: ACTIVE_COMPARATOR

Medical management

Intervention Type: OTHER

Interventions

Sleeve Gastrectomy

Intervention Type: PROCEDURE

Roux-en-Y Gastric Bypass

Intervention Type: PROCEDURE

Biliopancreatic Diversion with Duodenal Switch

Intervention Type: PROCEDURE

Medical management

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johnson & Johnson Medical Products

UNKNOWN

Sponsor Role: collaborator

Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

OTHER

Sponsor Role: collaborator

Laval University

OTHER

Sponsor Role: lead

Responsible Party

Laurent Biertho

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Institut Universitaire de Cardiologie et de Pneumologie de Québec

Québec, Quebec, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Melanie Nadeau, MSc

Role: CONTACT

melanie.nadeau@criucpq.ulaval.ca

418-656-8711 ext. 3490

Facility Contacts

Melanie Nadeau, MSc

Role: primary

melanie.nadeau@criucpq.ulaval.ca

418-565-8711 ext. 3490

Suzy Laroche

Role: backup

suzy_laroche@ssss.gouv.qc.ca

418-656-8711 ext. 4810

References

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.

Reference Type: DERIVED

PMID: 35739539 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31915151 (View on PubMed)

Other Identifiers

Remission

Identifier Type: -

Identifier Source: org_study_id