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

NCT02390973 — Not applicable, Recruiting, 408 participants, Laval University

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Registry	NCT02390973, acronym REMISSION
Status	Recruiting
Phase	Not applicable
Study type	Interventional; non randomized, parallel, masking: none, treatment
Enrollment	408 (Estimated)
Sponsor	Laval University (Other); collaborators: Johnson & Johnson K.K. Medical Company, Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Conditions	Bariatric Surgery Candidate, Diabetes
Interventions	Sleeve Gastrectomy, Roux-en-Y Gastric Bypass, Biliopancreatic Diversion with Duodenal Switch, Medical management (Procedure, other)
Dates	start 2015-03-01, primary completion 2027-03-01 (estimated), completion 2030-03-01 (estimated), first posted 2015-03-18, last updated 2025-12-08
Locations	1 site in Canada

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Sleeve gastrectomy	Active comparator	Procedure: Sleeve Gastrectomy
Roux-en-Y Gastric Bypass	Active comparator	Procedure: Roux-en-Y Gastric Bypass
Biliopancreatic Diversion	Active comparator	Procedure: Biliopancreatic Diversion with Duodenal Switch
Control	Active comparator	Other: Medical management	the best medical management of their diabetes, non-surgical group

Sleeve Gastrectomy (Procedure)
Roux-en-Y Gastric Bypass (Procedure)
Biliopancreatic Diversion with Duodenal Switch (Procedure)
Medical management (Other)

+Outcome measures

Primary outcomes

Type 2 diabetes remission rate [from baseline up to 60 months]: percent of patient achieving type 2 diabetes remission in each groups

Secondary outcomes

Change in microalbuminuria [from baseline up to 60 months]: Normalisation of A/C ratio after surgery
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
GERD remission rate [from baseline up to 60 months]: percent of patient achieving gastro-esophageal reflux disease resolution in each groups
Quality of life [from baseline up to 60 months]: quality of life after surgery eveluated with questionnaires
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)
Regression of liver disease [from baseline up to 60 months]: regression of liver disease documented by percutaneous liver biopsy after surgery
Dislipidemia remission [from baseline up to 60 months]: percent of patient achieving dislipidemia remission in each groups

Other outcomes

short-term complications [baseline up to 4 month]: comparaison of intra-operative, post-operative and in-hospital complications between groups using clavien classification
Long-term complications [baseline up to 60 months]: 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

+Eligibility

Sex: All, ages: 18 Years to 60 Years

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

+Locations (1)

Facility	City	Country	Status
Institut Universitaire de Cardiologie et de Pneumologie de Québec	Québec, Quebec	Canada	Recruiting

+Publications

Results publication: 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
Results publication: 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. PMID 31915151