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Comparisons of Metabolic Effect of Sleeve Gastrectomy With Duodenojejunal Bypass and Sleeve Gastrectomy (MEDUSA): A Multicenter Randomized Controlled Trial

RECRUITINGPhase 3Sponsored by Seoul National University Bundang Hospital
Actively Recruiting
PhasePhase 3
SponsorSeoul National University Bundang Hospital
Started2022-01-03
Est. completion2031-01-03
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT05211375

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

Age: 18 Years+Healthy volunteers accepted
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

Conditions5

AsiansBariatric SurgeryDiabetesDiabetes Mellitus, Type 2Surgical Procedures, Operative

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