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

Obesity Clinical Trial

— CONTROL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01984762
• Other study ID #: 684-11
• Status: Recruiting
• Phase: N/A
• Start date: September 2012
• Est. completion date: October 1, 2023

Study information

• Verified date: February 2023
• Source: Göteborg University
• Contact: Ville R Wallenius, MD, PhD, Assoc Prof
• Phone: +46313428206
• Email: ville.wallenius[@]gastro.gu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 134
• Est. completion date: October 1, 2023
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgery
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Obesity
• Type 2 Diabetes

Intervention

Procedure:
• Roux-en-Y gastric bypass
RYGBP=Roux-en-Y gastric bypass
• sleeve gastrectomy
SG = sleeve gastrectomy

Locations

Country	Name	City	State
Sweden	Sahlgrenska University Hospital	Gothenburg

Sponsors (1)

Lead Sponsor	Collaborator
Göteborg University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Glycemic control mechanisms	Oral glucose tolerance tests comparing blood glucose, insulin and and other gastrointestinal hormone levels within and between the intervention groups pre- and post-operatively.	5 years
Primary	Rate of resolution of type 2 diabetes		5 years
Secondary	postoperative complications	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.	5 years