RecruitingPhase 3NCT05211375

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


Sponsor

Seoul National University Bundang Hospital

Enrollment

130 participants

Start Date

Jan 3, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two types of weight-loss surgery for people with type 2 diabetes and obesity: standard sleeve gastrectomy (stomach reduction) versus sleeve gastrectomy combined with a small intestinal bypass. The goal is to find which surgery better controls blood sugar and potentially puts diabetes into remission. **You may be eligible if...** - You are over 18 years old - Your BMI is 27.5 kg/m² or higher - You have had type 2 diabetes for 10 years or less - You are using insulin, or your HbA1c (average blood sugar) is 7.0% or higher despite medication - You still produce some insulin (C-peptide level above 1.0 ng/mL) - You agree not to become pregnant for at least one year after surgery **You may NOT be eligible if...** - You have severe, uncontrolled acid reflux disease - You have had previous stomach or anti-reflux surgery - You have poorly controlled psychiatric illness requiring 3 or more psychiatric medications - You have attempted suicide in the past 12 months or have active substance abuse issues Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREDuodenojejunal bypass

Sleeve gastrectomy will be performed in the same manner as in the SG group. DJB will be performed by transection of the duodenum and bypassing 250 cm of the proximal jejunum. The handsewn suture will be used for duodenojejunal anastomosis, and the size of anastomosis will be 1.5 - 2 cm. Single anastomosis will be performed rather than Roux-en-Y fashion.

PROCEDURESleeve gastrectomy

Sleeve gastrectomy will be performed using 36-38 Fr bougie. The initial stapling start point will be between 4-6 cm from the pylorus, and the last stapling will be performed at least 1 cm away from His angle. The height of the automatic stapler will be selected based on the researcher's discretion.


Locations(1)

Seoul National University Bundang Hospital

Seongnam-si, South Korea

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NCT05211375


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