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Comparisons of Metabolic Effect of Sleeve Gastrectomy with Duodenojejunal Bypass and Sleeve Gastrectomy (MEDUSA): A multicenter randomized controlled trial

Comparisons of Metabolic Effect of Sleeve Gastrectomy with Duodenojejunal Bypass and Sleeve Gastrectomy (MEDUSA): A multicenter randomized controlled trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
CRIS
Registry ID
KCT0007174
Enrollment
130
Registered
2022-04-08
Start date
2022-02-24
Completion date
Unknown
Last updated
2022-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Procedure/Surgery : DJB group - Patients undergoing duodenojejunal bypass with sleeve gastrectomy SG group - Patients undergoing sleeve gastrectomy

Sponsors

Seoul National University Bundang Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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

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

Design outcomes

Primary

MeasureTime frame
Complete remission rate of type 2 diabetes

Secondary

MeasureTime frame
Complete remission/partial remission/improvement rate of type 2 diabetes;Complete remission/improvement rate of hypertension and hyperlipidemia;Complete remission/partial remission of type 2 diabetes;Changes in body composition;Prevalence of GERD;Changes in quality of life;complication rate;mortality rate;Trace element deficiency rate

Countries

Korea, Republic of

Contacts

Public ContactYoung Suk Park

Seoul National University Bundang Hospital

youngsukmd@gmail.com+82-2-787-7099

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026