Sleeve Gastrectomy and Roux-en-Y Gastric Bypass in the Treatment of Type 2 Diabetes Mellitus.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorGöteborg University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Type 2 diabetes mellitus
BMI between 35 and 50kg/m2.
Males and females
Age between 18 and 60 years.
Disqualifiers
Severe ongoing psychiatric disorder, alcoholism and substance abuse.
Redo operations after previous bariatric procedures.
Type 1 diabetes or other non-type 2 forms of diabetes
End stage renal disease, retinopathy, neuropathy
Trial design
Design model
Parallel
Treatments tested in this trial
Roux-en-Y gastric bypass
Procedure/SurgeryRYGBP=Roux-en-Y gastric bypass
sleeve gastrectomy
Procedure/SurgerySG = sleeve gastrectomy
Treatment groups
134 Participants
are divided into 2 treatment groupsGroup A: RYGBPActive comparator 1 intervention
Group B: SGActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Rate of resolution of type 2 diabetes
Time frame
5 yearsSecondary outcomes
1
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.
Time frame
5 yearsOther outcomes
1
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.
Time frame
5 yearsSponsors and contacts
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Source ClinicalTrials.gov