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

Göteborg University

Status: Enrolling

Conditions: Bariatric Surgery; Obesity; Type 2 Diabetes

Treatments: Procedure: sleeve gastrectomy; Procedure: Roux-en-Y gastric bypass

Study type: Interventional

Funder types: Other

Identifiers

NCT01984762

684-11

Details and patient eligibility

About

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.

Enrollment: 134 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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134 participants in 2 patient groups

RYGBP

Active Comparator group

Description:

Roux-en-Y gastric bypass

Treatment:

Procedure: Roux-en-Y gastric bypass

SG

Active Comparator group

Description:

sleeve gastrectomy

Treatment:

Procedure: sleeve gastrectomy