Actively Recruiting
Comparisons of Metabolic Effect of Sleeve Gastrectomy With Duodenojejunal Bypass and Sleeve Gastrectomy (MEDUSA): A Multicenter Randomized Controlled Trial
Led by Seoul National University Bundang Hospital · Updated on 2022-01-27
130
Participants Needed
1
Research Sites
730 weeks
Total Duration
On this page
Sponsors
S
Seoul National University Bundang Hospital
Lead Sponsor
A
Ajou University School of Medicine
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Comparisons of Metabolic Effect of Sleeve Gastrectomy With Duodenojejunal Bypass and Sleeve Gastrectomy (MEDUSA): A Multicenter Randomized Controlled Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 18 years
- BMI equal to or greater than 27.5 kg/m2
- Type 2 diabetes diagnosed 10 years ago or less
- Using insulin or having HbA1c of 7.0% or higher while taking diabetes medication
- C-peptide level higher than 1.0 ng/mL
- Consent to avoid pregnancy for at least 1 year after surgery
- Willingness to provide voluntary informed consent
You will not qualify if you...
- Uncontrolled severe gastroesophageal reflux (LA classification C or higher)
- Previous metabolic surgery for type 2 diabetes
- Past gastrointestinal surgeries like gastrectomy or anti-reflux surgery affecting metabolic surgery results
- Taking more than 3 psychiatric drugs due to poorly controlled psychiatric disorders
- Suicide attempts within the last 12 months
- Treatment for alcohol or drug abuse within the last 12 months
- Mental incapacity, pregnancy, planning pregnancy, or lactation
- Unsuitability as judged by the researcher
AI-Screening
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Trial Site Locations
Total: 1 location
1
Seoul National University Bundang Hospital
Seongnam-si, South Korea, 13620
Actively Recruiting
Research Team
Y
Young Suk Park
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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