Bariatric Surgery, Obesity, Type 2 Diabetes
Conditions
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.
Interventions
PROCEDURERoux-en-Y gastric bypass
RYGBP=Roux-en-Y gastric bypass
PROCEDUREsleeve gastrectomy
SG = sleeve gastrectomy
Sponsors
Göteborg University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of resolution of type 2 diabetes | 5 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Sweden
Contacts
Primary ContactVille R Wallenius, MD, PhD, Assoc Prof
Backup ContactAlmantas Maleckas
Outcome results
None listed