Bariatric Surgery Candidate study: Sleeve Gastrectomy vs Roux-en-Y Gastric Bypass
Official title Surgery Versus Best Medical Management for the Long Term Remission of Type 2 Diabetes and Related Diseases (REMISSION)
ClinicalTrials.gov ID: NCT02390973
What this study is testing
- What it's testing
- The study aims to find out how long the benefits of different weight-loss surgeries last for people with type 2 diabetes. It also looks at how these surgeries affect kidney and heart health compared to standard medical treatment.
- Who it's for
- The study is looking for people with type 2 diabetes who are candidates for weight-loss surgery.
- What's involved
- Participants will either have one of three types of weight-loss surgery or receive standard medical care for their diabetes. They will undergo regular health checks to monitor their blood sugar, kidney function, heart health, and quality of life.
- Time commitment
- The study is a long-term follow-up to track health changes over time, requiring regular visits for testing and monitoring.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join if
- BMI ≥ 35
- type 2 diabetes
- HbA1c ≥ 6,5 % or fasting glycemia ≥7mmol/l or non-fasting glycemia ≥11mmol/l
- able to consent
You likely can't join if
- 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
See the full eligibility criteria
- BMI ≥ 35
- type 2 diabetes
- HbA1c ≥ 6,5 % or fasting glycemia ≥7mmol/l or non-fasting glycemia ≥11mmol/l
- able to consent
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Québec, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Québec, Quebec, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.