NCT02390973Recruiting
Surgery Versus Best Medical Management for the Long Term Remission of Type 2 Diabetes and Related Diseases (REMISSION)
Source: ClinicalTrials.gov · Last updated 8 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 408 (estimated)
- First submitted
- 16 Feb 2015
- Start date
- 1 Mar 2015
- Primary completion date
- 31 Mar 2027
- Lead sponsor
- Laval University
- Diseases
- Type 2 diabetes
- NCT number
- NCT02390973
What you commit to
- Study type: Interventional
- Planned participants: 408
- From 1 Mar 2015 to the primary completion date, 31 Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- past esophageal, gastric or bariatric surgery
- taken of corticosteroid in the last month
Other illness
- history of gastric or duodenal ulcers
- history of renal, hepatic, cardiac or pulmonary severe disease
- history of drug use or alcool abuse in the last 12 months
- history of gastro-intestinal inflammatory diseases
Other
- pregnancy
- irritable bowel, unexplained intermittent vomiting, severe abdominal pain, chronic diarrhea or constipation
- pre-operatory hypoalbuminemy
- evidence of psycological problem that may affect the capacity to understand the project and to comply with the medical recommandations
Who the study is looking for
- BMI ≥ 35
- type 2 diabetes
- HbA1c ≥ 6,5 % or fasting glycemia ≥7mmol/l or non-fasting glycemia ≥11mmol/l
- able to consent
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institut universitaire de cardiologie et de pneumologie de Québec Coordinator of this site? Confirm its status | Québec | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.