Clinical trial NCT02390973: Surgery Versus Best Medical Management for the Long Term Remission of Type 2 Diabetes and Related Diseases (REMISSION)
Official title: Surgery Versus Best Medical Management for the Long Term Remission of Type 2 Diabetes and Related Diseases (REMISSION)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bariatric Surgery Candidate
Diabetes
Lead sponsor: Laval University
Sponsor class: OTHER
Collaborators: name: Johnson & Johnson Medical Products
name: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
First posted: 2015-03-18
Enrollment: 408
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Type 2 diabetes remission rate
timeFrame: from baseline up to 60 months
Secondary outcomes:
measure: Change in microalbuminuria
timeFrame: from baseline up to 60 months
measure: Change in retinopathy
timeFrame: from baseline up to 60 months
measure: Hypertension remission rate
timeFrame: from baseline up yo 60 months
measure: GERD remission rate
timeFrame: from baseline up to 60 months
measure: Quality of life
timeFrame: from baseline up to 60 months
measure: Sleep apnea remission rate
timeFrame: from baseline up to 60 months
measure: weight loss
timeFrame: from baseline up to 60 months
measure: Regression of liver disease
timeFrame: from baseline up to 60 months
measure: Dislipidemia remission
timeFrame: from baseline up to 60 months
Other outcomes:
measure: short-term complications
timeFrame: baseline up to 4 month
measure: Long-term complications
timeFrame: baseline up to 60 months
Locations:
city: Québec
country: Canada
facility: Institut Universitaire de Cardiologie et de Pneumologie de Québec
Study officials:
References:
citation: 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.
citation: 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.