NCT05211375RecruitingPhase 3
Comparisons of Metabolic Effect of Sleeve Gastrectomy With Duodenojejunal Bypass and Sleeve Gastrectomy (MEDUSA): A Multicenter Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 27 Jan 2022 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 130 (estimated)
- First submitted
- 4 Jan 2022
- Start date
- 3 Jan 2022
- Primary completion date
- 3 Jan 2031
- Lead sponsor
- Seoul National University Bundang Hospital
- Diseases
- Type 2 diabetes
- NCT number
- NCT05211375
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 130
- From 3 Jan 2022 to the primary completion date, 3 Jan 2031
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of previous metabolic surgery for T2DM
- Treatment for alcohol and drug abuse within the last 12 months
Other illness
- 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
Other
- Presence of uncontrolled severe gastroesophageal reflux (LA classification C or more in esophagogastroduodenoscopy)
- Suicidal attempts within the last 12 months
- Vulnerability factors (lacking mental capacity, pregnancy or planning of pregnancy, lactation)
- Unsuitability as per the discretion of the researcher
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Seoul National University Bundang Hospital Coordinator of this site? Confirm its status | Seongnam-si | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.