Comparing surgery and medical management for long-term diabetes remission
Surgery Versus Best Medical Management for the Long Term Remission of Type 2 Diabetes and Related Diseases (REMISSION)
This study is testing whether different types of weight-loss surgery can help people with type 2 diabetes improve their health more than just taking medication.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 408 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Laval University Academic / other |
| Locations | 1 site (Québec, Quebec) |
| Trial ID | NCT02390973 on ClinicalTrials.gov |
What this trial studies
This study investigates the long-term effects of three types of bariatric surgeries—Roux-en-Y Gastric Bypass, Sleeve Gastrectomy, and Biliopancreatic Diversion with Duodenal Switch—on patients with type 2 diabetes. It aims to measure metabolic, renal, and cardiovascular outcomes, hypothesizing that these surgeries may have unrecognized benefits for diabetic patients. The study will involve a longitudinal approach to assess the impact of these surgical interventions compared to best medical management.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals with a BMI of 35 or higher who have been diagnosed with type 2 diabetes.
Not a fit: Patients with a history of severe gastrointestinal diseases or those who have undergone previous bariatric surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved long-term management and remission of type 2 diabetes for patients undergoing bariatric surgery.
How similar studies have performed: Previous studies have shown promising results for bariatric surgery in improving diabetes outcomes, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Québec, Quebec
- Institut Universitaire de Cardiologie et de Pneumologie de Québec — Québec, Quebec, Canada (Recruiting)
Study contacts
- Study coordinator: Melanie Nadeau, MSc
- Email: melanie.nadeau@criucpq.ulaval.ca
- Phone: 418-656-8711
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.