Comparing two surgical methods for treating type 2 diabetes
Official title: Comparisons of Metabolic Effect of Sleeve Gastrectomy With Duodenojejunal Bypass and Sleeve Gastrectomy (MEDUSA): A Multicenter Randomized Controlled Trial
Run by Seoul National University Bundang Hospital · NCT05211375 · Data updated 2026-11-12
This study is testing whether a combined surgery for type 2 diabetes can help people with poor blood sugar control feel better than just one type of surgery alone.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 130 (estimated) |
| Sponsor | Seoul National University Bundang Hospital Academic / other |
| Locations | 1 site (Seongnam-si) |
| Status | Recruiting |
| Started | January 3, 2022 |
| Main results expected | January 3, 2031 |
| Study ends | January 3, 2036 |
| Registry record updated | January 27, 2022 |
| Trial ID | NCT05211375 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults over 18 with a BMI of 27.5 kg/m2 or higher, diagnosed with T2DM for 10 years or less, and experiencing poor blood sugar control.
✕Probably not a fit
Patients with uncontrolled severe gastroesophageal reflux, previous metabolic surgeries, or significant psychiatric disorders may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial compares the metabolic effects of sleeve gastrectomy with duodenojejunal bypass (SG with DJB) against sleeve gastrectomy (SG) alone in patients with type 2 diabetes mellitus (T2DM). It targets individuals with poor blood sugar control despite medical treatment, specifically those who have been using insulin or diabetic medications for less than 10 years. The study aims to determine if SG with DJB provides superior outcomes for T2DM management compared to SG alone, particularly in Asian patients who may have unique metabolic surgery needs. The trial will involve multiple centers and will assess the efficacy of these surgical interventions in improving diabetes control.
Why it matters
Potential benefit: If successful, this study could lead to improved diabetes management and remission for patients with type 2 diabetes.
How similar studies have gone: While there is limited research on SG with DJB specifically for T2DM in Asian populations, similar metabolic surgery approaches have shown promise in other studies.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where it's running
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Seoul National University Bundang Hospital
Seongnam-si, South Korea Recruiting
Study contacts
- Principal investigator: Young Suk Park — Seoul National University Bundang Hospital
- Study coordinator: Young Suk Park
- Email: youngsukmd@gmail.com
- Phone: +82-10-8980-6094
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.