Sleeve Gastrectomy and Roux-en-Y Gastric Bypass in the Treatment of Type 2 Diabetes Mellitus.

Not Applicable

Recruiting

• Conditions: Bariatric Surgery; Obesity; Type 2 Diabetes
• Interventions: Procedure: Roux-en-Y gastric bypass; Procedure: sleeve gastrectomy

• Registration Number: NCT01984762
• Lead Sponsor: Göteborg University

Brief Summary

Obesity is a growing epidemic throughout the world and is followed by increasing incidence of type 2 diabetes that accounts for 90-95% of all cases of diabetes. Weight loss is a major objective, although difficult to achieve with medical treatments. Many recent studies demonstrated that bariatric surgery has the potency to achieve marked and sustained weight loss, and is also associated with a significant improvement in control of type 2 diabetes. The principal aim of this study is to compare two types of bariatric procedures, the Roux-en-Y gastric bypass (RYGBP) and sleeve gastrectomy (SG). The study hypothesis is that these procedures have equal efficacy with regard to resolution of type 2 diabetes.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2013-10-29
• Study First Submitted QC: 2013-11-14
• Study First Posted: 2013-11-15
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-24
• Last Update Posted: 2025-04-25
• Primary Completion: 2025-10-01
• Study Completion: 2025-10-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 134

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RYGBP	Roux-en-Y gastric bypass	Roux-en-Y gastric bypass
SG	sleeve gastrectomy	sleeve gastrectomy

Primary Outcome Measures

Name	Time	Method
Rate of resolution of type 2 diabetes	5 years

Secondary Outcome Measures

Name	Time	Method
postoperative complications	5 years	Post-operative (within 30 days) bleeding, staple line/anastomotic leakage, infection, deep venous thrombosis, pulmonary embolism, resubmission. Questionnaires for health related quality of life (SF-36), gastroesophageal reflux symptoms (Carlsson-Dent), gastrointestinal symptom rating scale (GSRS) and food intake (SOS food questionnaire), recorded pre-operatively and at 6 weeks to 60 months post-operatively.

Trial Locations

Locations (1)

Sahlgrenska University Hospital; 🇸🇪 Gothenburg, Sweden