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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01984762
Recruitment Status : Recruiting
First Posted : November 15, 2013
Last Update Posted : August 14, 2017
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Obesity Type 2 Diabetes Bariatric Surgery Procedure: Roux-en-Y gastric bypass Procedure: sleeve gastrectomy Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 134 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sleeve Gastrectomy and Roux-en-Y Gastric Bypass in the Treatment of Type 2 Diabetes Mellitus. Randomised Controlled Trial
Study Start Date : September 2012
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: RYGBP
Roux-en-Y gastric bypass
Procedure: Roux-en-Y gastric bypass
RYGBP=Roux-en-Y gastric bypass
Active Comparator: SG
sleeve gastrectomy
Procedure: sleeve gastrectomy
SG = sleeve gastrectomy

Primary Outcome Measures :
  1. Rate of resolution of type 2 diabetes [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. postoperative complications [ Time Frame: 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.

Other Outcome Measures:
  1. Glycemic control mechanisms [ Time Frame: 5 years ]
    Oral glucose tolerance tests comparing blood glucose, insulin and and other gastrointestinal hormone levels within and between the intervention groups pre- and post-operatively.

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01984762

Contact: Ville R Wallenius, MD, PhD, Assoc Prof +46313428206
Contact: Almantas Maleckas +37068531143

Sahlgrenska University Hospital Recruiting
Gothenburg, Sweden, SE41345
Contact: Ville R Wallenius, MD, PhD, Assoc Prof    +46313428206   
Sponsors and Collaborators
Göteborg University
Study Chair: Lars Fändriks, MD, PhD, Professor Göteborg University

Responsible Party: Göteborg University Identifier: NCT01984762     History of Changes
Other Study ID Numbers: 684-11
First Posted: November 15, 2013    Key Record Dates
Last Update Posted: August 14, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases