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

Not Applicable

Recruiting

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

• Registration Number: NCT02390973
• Lead Sponsor: Laval University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-02-16
• Study Start: 2015-03
• Study First Submitted QC: 2015-03-11
• Study First Posted: 2015-03-18
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-06
• Last Update Posted: 2024-08-09
• Primary Completion: 2025-03
• Study Completion: 2029-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 408

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Biliopancreatic Diversion	Biliopancreatic Diversion with Duodenal Switch	-
Control	Medical management	the best medical management of their diabetes, non-surgical group
Sleeve gastrectomy	Sleeve Gastrectomy	-
Roux-en-Y Gastric Bypass	Roux-en-Y Gastric Bypass	-

Primary Outcome Measures

Name	Time	Method
Type 2 diabetes remission rate	from baseline up to 60 months	percent of patient achieving type 2 diabetes remission in each groups

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Institut Universitaire de Cardiologie et de Pneumologie de Québec; 🇨🇦 Québec, Canada