Comparisons of Metabolic Effect of Sleeve Gastrectomy with Duodenojejunal Bypass and Sleeve Gastrectomy (MEDUSA): A multicenter randomized controlled trial
- Conditions
- Endocrine, nutritional and metabolic diseases
- Registration Number
- KCT0007174
- Lead Sponsor
- Seoul National University Bundang Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 130
Age over 18 years
BMI equal to or greater than 27.5 kg/m2
T2DM duration = 10 years
Using insulin, or HbA1c = 7.0% while taking diabetes medication
C-peptide level higher than 1.0 ng/mL
Presence of type 2 diabetes fulfilling the following criteria
Consent to not become pregnant for at least 1 year after surgery
Willingness to provide voluntary informed consent
Presence of uncontrolled severe gastroesophageal reflux (LA classification C or more in esophagogastroduodenoscopy)
History of previous metabolic surgery for T2DM
History of gastrointestinal surgery, such as gastrectomy or anti-reflux surgery, which may affect the result of metabolic surgery
Therapy regimen of more than 3 psychiatric drugs owing to poorly controlled psychiatric disorders
Suicidal attempts within the last 12 months
Treatment for alcohol and drug abuse within the last 12 months
Vulnerability factors (lacking mental capacity, pregnancy or planning of pregnancy, lactation)
Unsuitability as per the discretion of the researcher
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Complete remission rate of type 2 diabetes
- Secondary Outcome Measures
Name Time Method Complete remission/partial remission/improvement rate of type 2 diabetes;Complete remission/improvement rate of hypertension and hyperlipidemia;Complete remission/partial remission of type 2 diabetes;Changes in body composition;Prevalence of GERD;Changes in quality of life;complication rate;mortality rate;Trace element deficiency rate