Comparing two types of weight loss surgery for type 2 diabetes treatment
Sleeve Gastrectomy and Roux-en-Y Gastric Bypass in the Treatment of Type 2 Diabetes Mellitus. Randomised Controlled Trial
This study is testing whether two types of weight loss surgery can help people with obesity and type 2 diabetes improve their condition.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 134 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Göteborg University Academic / other |
| Locations | 1 site (Gothenburg) |
| Trial ID | NCT01984762 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of two bariatric surgical procedures, Roux-en-Y gastric bypass and sleeve gastrectomy, in treating type 2 diabetes mellitus in obese patients. It focuses on patients with a body mass index (BMI) between 35 and 50 kg/m², aged 18 to 60 years. The primary goal is to determine if both surgical options provide similar outcomes in terms of diabetes resolution. The study is significant as it addresses the growing obesity epidemic and its link to diabetes management.
Who should consider this trial
Good fit: Ideal candidates for this study are obese individuals aged 18 to 60 with type 2 diabetes and a BMI between 35 and 50 kg/m².
Not a fit: Patients with type 1 diabetes, severe psychiatric disorders, or those who have undergone previous bariatric surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into optimal surgical options for achieving better diabetes control in obese patients.
How similar studies have performed: Previous studies have shown promising results for bariatric surgery in improving type 2 diabetes, suggesting that this approach is well-supported by existing evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Type 2 diabetes mellitus 2. BMI between 35 and 50kg/m2. 3. Males and females 4. Age between 18 and 60 years. Exclusion Criteria: 1. Severe ongoing psychiatric disorder, alcoholism and substance abuse. 2. Redo operations after previous bariatric procedures. 3. Type 1 diabetes or other non-type 2 forms of diabetes 4. End stage renal disease, retinopathy, neuropathy
Where this trial is running
Gothenburg
- Sahlgrenska University Hospital — Gothenburg, Sweden (Recruiting)
Study contacts
- Study coordinator: Ville R Wallenius, MD, PhD, Assoc Prof
- Email: ville.wallenius@gastro.gu.se
- Phone: +46313428206
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.