NCT05211375 Comparisons of Metabolic Effect of Sleeve Gastrectomy With Duodenojejunal Bypass and Sleeve Gastrectomy (MEDUSA): A Multicenter Randomized Controlled Trial
| NCT ID | NCT05211375 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Seoul National University Bundang Hospital |
| Condition | Diabetes Mellitus, Type 2 |
| Study Type | INTERVENTIONAL |
| Enrollment | 130 participants |
| Start Date | 2022-01-03 |
| Primary Completion | 2031-01-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 130 participants in total. It began in 2022-01-03 with a primary completion date of 2031-01-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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
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
Contact & Investigator
Young Suk Park
PRINCIPAL INVESTIGATOR
Seoul National University Bundang Hospital
Frequently Asked Questions
Who can join the NCT05211375 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Diabetes Mellitus, Type 2. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05211375 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 130 participants.
Is NCT05211375 currently recruiting?
Yes, NCT05211375 is actively recruiting participants. Contact the research team at youngsukmd@gmail.com for enrollment information.
Where is the NCT05211375 trial being conducted?
This trial is being conducted at Seongnam-si, South Korea.
Who is sponsoring the NCT05211375 clinical trial?
NCT05211375 is sponsored by Seoul National University Bundang Hospital. The principal investigator is Young Suk Park at Seoul National University Bundang Hospital. The trial plans to enroll 130 participants.
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