Status:
RECRUITING
Comparisons of Metabolic Effect of Sleeve Gastrectomy With Duodenojejunal Bypass and Sleeve Gastrectomy (MEDUSA): A Multicenter Randomized Controlled Trial
Lead Sponsor:
Seoul National University Bundang Hospital
Collaborating Sponsors:
Ajou University School of Medicine
The Catholic University of Korea
Conditions:
Diabetes Mellitus, Type 2
Bariatric Surgery
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
In this study, the effects of SG with DJB and SG alone for the treatment of type 2 diabetes mellitus (T2DM) will be compared in patients other than the two groups at both extremes who are expected to ...
Detailed Description
Most Asian patients undergoing metabolic surgery for the treatment of T2DM have BMI as low as 30-35 kg/m2. If SG is performed for the treatment of T2DM in these patients, weight may decrease after the...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
January 3 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 3 2036
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT05211375
Start Date
January 3 2022
End Date
January 3 2036
Last Update
January 27 2022
Active Locations (1)
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1
Seoul National University Bundang Hospital
Seongnam-si, South Korea, 13620