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Comparisons of Metabolic Effect of Sleeve Gastrectomy With Duodenojejunal Bypass and Sleeve Gastrectomy (MEDUSA): A Multicenter Randomized Controlled Trial

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
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 show excellent effects of metabolic surgery with SG alone (mild T2DM) and who need SG with DJB (severe T2DM). This study is to target patients with poor blood sugar control despite current medical treatment, although the beta-cell function of the pancreas is preserved. Therefore, this study is aimed at patients who have been using insulin for less than 10 years with T2DM, or taking diabetic medications with HbA1c ≥ 7.0% for less than 10 years with T2DM. The investigators hypothesize that the treatment effects of SG with DJB for T2DM will be superior to that of SG in this group
Trial Details
NCT Number NCT05211375
Lead Sponsor Seoul National University Bundang Hospital
Collaborators: Ajou University School of Medicine, The Catholic University of Korea, The Catholic University of Korea Eunpyeong St. Mary's Hospital, Ewha Womans University Seoul Hospital, Seoul Metropolitan Boramae Hospital, Soonchunhyang University Hospital, Korea University
Conditions
(from sponsor)		 Diabetes Mellitus, Type 2, Bariatric Surgery, Surgical Procedures, Operative, Asians
Related terms Diabetes Mellitus, Type 2
Enrollment 130 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov