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

Launched by SEOUL NATIONAL UNIVERSITY BUNDANG HOSPITAL · Jan 13, 2022

Keywords

ClinConnect Summary

The MEDUSA trial is studying two types of weight-loss surgeries, sleeve gastrectomy (SG) alone and sleeve gastrectomy with duodenojejunal bypass (SG with DJB), to see which is more effective in improving blood sugar control for people with type 2 diabetes mellitus (T2DM). This study is aimed at adults who have been struggling to manage their diabetes despite taking medication or insulin for less than 10 years. Eligible participants are those aged 18 and older, with a body mass index (BMI) of 27.5 or higher, and specific blood sugar levels that show their diabetes is not well controlled.

If you join the trial, you will be randomly assigned to one of the two surgery groups and monitored closely to see how well each surgery helps manage your diabetes over time. It's important to note that participants should be willing to avoid pregnancy for at least a year after the surgery and must give informed consent to take part in the study. This trial is currently recruiting participants, so if you're interested and meet the criteria, it could be a great opportunity to explore new treatment options for your diabetes.

Gender

ALL

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 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

Trial Officials