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

Sponsor
Göteborg University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT01984762
Collaborator
(none)
134
Enrollment
1
Location
2
Arms
120
Anticipated Duration (Months)
1.1
Patients Per Site Per Month

Study Details

Study Description

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
  • Procedure: Roux-en-Y gastric bypass
  • Procedure: sleeve gastrectomy
 N/A

Study Design

Study Type:
Interventional
Anticipated 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
Actual Study Start Date :
Sep 1, 2012
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Sep 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Rate of resolution of type 2 diabetes [5 years]

Secondary Outcome Measures

  1. 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.

Other Outcome Measures

  1. Glycemic control mechanisms [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sahlgrenska University Hospital Gothenburg Sweden SE41345

Sponsors and Collaborators

  • Göteborg University

Investigators

  • Study Chair: Lars Fändriks, MD, PhD, Professor, Göteborg University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Göteborg University
ClinicalTrials.gov Identifier:
NCT01984762
Other Study ID Numbers:
  • 684-11
First Posted:
Nov 15, 2013
Last Update Posted:
Oct 11, 2021
Last Verified:
Oct 1, 2021
Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Oct 11, 2021