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

Study Overview
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Brief Summary
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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.

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

Conditions
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Bariatric Surgery Candidate, Diabetes

Intervention / Treatment
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* Procedure: Sleeve Gastrectomy
* Procedure: Roux-en-Y Gastric Bypass
* Procedure: Biliopancreatic Diversion with Duodenal Switch
* Other: Medical management


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |