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

NCT05211375 | Recruiting Phase 3 DMC

• 1 other identifier: MEDUSA
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Diabetes Mellitus, Type 2; Bariatric Surgery; Surgical Procedures, Operative; Asians

Keywords

Bariatric Surgery; Metabolic Surgery; Diabetes Remission

Outcome Measures

Primary Outcomes (1)

• Complete remission rate of type 2 diabetes

  HbA1c \<6% (or fasting blood glucose \[FBG\] \<100 mg/dL) without using any diabetes medication

  5 years after surgery

Secondary Outcomes (14)

• Complete remission rate of type 2 diabetes

  1, 3, 10 years after surgery

• Partial remission rate of type 2 diabetes

  1, 3, 5, 10 years after surgery

• Improvement rate of type 2 diabetes

  1, 3, 5, 10 years after surgery

• Hypertension remission rate

  1, 3, 5, 10 years after surgery

• Hypertension improvement rate

  1, 3, 5, 10 years after surgery

Study Arms (2)

SG group

ACTIVE COMPARATOR

Patients undergoing sleeve gastrectomy

Procedure: Sleeve gastrectomy

DJB group

EXPERIMENTAL

Patients undergoing duodenojejunal bypass with sleeve gastrectomy

Procedure: Duodenojejunal bypass

Interventions

Duodenojejunal bypass PROCEDURE

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.

DJB group

Sleeve gastrectomy PROCEDURE

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.

SG group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead
• Ajou University School of Medicine: collaborator
• The Catholic University of Korea: collaborator
• The Catholic University of Korea Eunpyeong St. Mary's Hospital: collaborator
• Ewha University Seoul Hospital: collaborator
• Seoul Metropolitan Boramae Hospital: collaborator
• Soonchunhyang University Hospital: collaborator
• Korea University: collaborator

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, 13620, South Korea

RECRUITING

Related Publications (3)

• Hofso D, Fatima F, Borgeraas H, Birkeland KI, Gulseth HL, Hertel JK, Johnson LK, Lindberg M, Nordstrand N, Cvancarova Smastuen M, Stefanovski D, Svanevik M, Gretland Valderhaug T, Sandbu R, Hjelmesaeth J. Gastric bypass versus sleeve gastrectomy in patients with type 2 diabetes (Oseberg): a single-centre, triple-blind, randomised controlled trial. Lancet Diabetes Endocrinol. 2019 Dec;7(12):912-924. doi: 10.1016/S2213-8587(19)30344-4. Epub 2019 Oct 31.

  PMID: 31678062 BACKGROUND

• Aminian A, Brethauer SA, Andalib A, Nowacki AS, Jimenez A, Corcelles R, Hanipah ZN, Punchai S, Bhatt DL, Kashyap SR, Burguera B, Lacy AM, Vidal J, Schauer PR. Individualized Metabolic Surgery Score: Procedure Selection Based on Diabetes Severity. Ann Surg. 2017 Oct;266(4):650-657. doi: 10.1097/SLA.0000000000002407.

  PMID: 28742680 BACKGROUND

• Brethauer SA, Kim J, el Chaar M, Papasavas P, Eisenberg D, Rogers A, Ballem N, Kligman M, Kothari S; ASMBS Clinical Issues Committee. Standardized outcomes reporting in metabolic and bariatric surgery. Surg Obes Relat Dis. 2015 May-Jun;11(3):489-506. doi: 10.1016/j.soard.2015.02.003. No abstract available.

  PMID: 26093765 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Young Suk Park

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Young Suk Park

CONTACT

+82-10-8980-6094; youngsukmd@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: January 4, 2022
• First Posted: January 27, 2022
• Study Start: January 3, 2022
• Primary Completion (Estimated): January 3, 2031
• Study Completion (Estimated): January 3, 2036
• Last Updated: January 27, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)