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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorSeoul National University Bundang Hospital

About this trial

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

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Duodenojejunal bypass
  • Sleeve gastrectomy

Treatment groups

130 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Seoul National University Bundang Hospital

Lead sponsor

Ajou University School of Medicine

Collaborator

The Catholic University of Korea

Collaborator

The Catholic University of Korea Eunpyeong St. Mary's Hospital

Collaborator

Ewha Womans University Seoul Hospital

Collaborator

Seoul Metropolitan Boramae Hospital

Collaborator

Soonchunhyang University Hospital

Collaborator

Korea University

Collaborator