Comparisons of Metabolic Effect of Sleeve Gastrectomy With Duodenojejunal Bypass and Sleeve Gastrectomy (MEDUSA): A Multicenter Randomized Controlled Trial
Recruiting
Phase 3
Interventional Study
Diabetes Mellitus, Type 2
Bariatric Surgery
Surgical Procedures, Operative
Asians
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 130 (estimated)
- Sponsor
- Seoul National University Bundang Hospital · Other
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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 tr…
Trial Locations
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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 bec…
Contacts