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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Göteborg University
Sponsor:
Information provided by (Responsible Party):
Göteborg University
ClinicalTrials.gov Identifier:
NCT01984762
First received: October 29, 2013
Last updated: June 5, 2014
Last verified: June 2014
  Purpose

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 Intervention
Obesity
Type 2 Diabetes
Bariatric Surgery
Procedure: Roux-en-Y gastric bypass
Procedure: sleeve gastrectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Göteborg University:

Primary Outcome Measures:
  • Rate of resolution of type 2 diabetes [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • postoperative complications [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    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:
  • Glycemic control mechanisms [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Oral glucose tolerance tests comparing blood glucose, insulin and and other gastrointestinal hormone levels within and between the intervention groups pre- and post-operatively.


Estimated Enrollment: 134
Study Start Date: September 2012
Estimated Study Completion Date: September 2020
Estimated Primary Completion Date: September 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01984762

Contacts
Contact: Ville R Wallenius, MD, PhD, Assoc Prof +46313428206 ville.wallenius@gastro.gu.se
Contact: Almantas Maleckas +37068531143 almantas_maleckas@yahoo.com

Locations
Sweden
Sahlgrenska University Hospital Recruiting
Gothenburg, Sweden, SE41345
Contact: Ville R Wallenius, MD, PhD, Assoc Prof    +46313428206    ville.wallenius@gastro.gu.se   
Sponsors and Collaborators
Göteborg University
Investigators
Study Chair: Lars Fändriks, MD, PhD, Professor Göteborg University
  More Information

No publications provided

Responsible Party: Göteborg University
ClinicalTrials.gov Identifier: NCT01984762     History of Changes
Other Study ID Numbers: 684-11
Study First Received: October 29, 2013
Last Updated: June 5, 2014
Health Authority: Sweden: National Ethical Review Board

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

ClinicalTrials.gov processed this record on October 30, 2014