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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01984762
Other study ID # 684-11
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 2012
Est. completion date October 1, 2023

Study information

Verified date February 2023
Source Göteborg University
Contact Ville R Wallenius, MD, PhD, Assoc Prof
Phone +46313428206
Email ville.wallenius@gastro.gu.se
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 134
Est. completion date October 1, 2023
Est. primary completion date October 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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

Study Design


Intervention

Procedure:
Roux-en-Y gastric bypass
RYGBP=Roux-en-Y gastric bypass
sleeve gastrectomy
SG = sleeve gastrectomy

Locations

Country Name City State
Sweden Sahlgrenska University Hospital Gothenburg

Sponsors (1)

Lead Sponsor Collaborator
Göteborg University

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Other 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. 5 years
Primary Rate of resolution of type 2 diabetes 5 years
Secondary 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. 5 years
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