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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Republic of Korea
Seoul National University Bundang Hospital
RECRUITING
Seongnam-si
Contact Information
Primary
Young Suk Park
youngsukmd@gmail.com
+82-10-8980-6094
Time Frame
Start Date: 2022-01-03
Estimated Completion Date: 2036-01-03
Participants
Target number of participants: 130
Treatments
Active_comparator: SG group
Patients undergoing sleeve gastrectomy
Experimental: DJB group
Patients undergoing duodenojejunal bypass with sleeve gastrectomy
Sponsors
Collaborators: The Catholic University of Korea, Seoul Metropolitan Boramae Hospital, Ajou University School of Medicine, Korea University, Soonchunhyang University Hospital, The Catholic University of Korea Eunpyeong St. Mary's Hospital, Ewha University Seoul Hospital
Leads: Seoul National University Bundang Hospital

This content was sourced from clinicaltrials.gov