Surgery Versus Best Medical Management for the Long Term Remission of Type 2 Diabetes and Related Diseases (REMISSION)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sleeve Gastrectomy, Roux-en-Y Gastric Bypass, Biliopancreatic Diversion with Duodenal Switch, Medical management.
- Who it may be relevant to
- Registry conditions: Bariatric Surgery Candidate, Diabetes. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Procedure Sleeve Gastrectomy
- Procedure Roux-en-Y Gastric Bypass
- Procedure Biliopancreatic Diversion with Duodenal Switch
- Other Medical management
Primary outcome measures
- Type 2 diabetes remission rate [Time frame: from baseline up to 60 months]
Secondary outcome measures (9)
- Change in microalbuminuria [Time frame: from baseline up to 60 months]
- Change in retinopathy [Time frame: from baseline up to 60 months]
- Hypertension remission rate [Time frame: from baseline up yo 60 months]
- GERD remission rate [Time frame: from baseline up to 60 months]
- Quality of life [Time frame: from baseline up to 60 months]
- Sleep apnea remission rate [Time frame: from baseline up to 60 months]
- weight loss [Time frame: from baseline up to 60 months]
- Regression of liver disease [Time frame: from baseline up to 60 months]
- Dislipidemia remission [Time frame: from baseline up to 60 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Canada · 1 center
- Institut Universitaire de Cardiologie et de Pneumologie de Québec — Québec
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. PMID 35739539
- 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. do PMID 31915151
Identifiers
NCT: NCT02390973 · Remission