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

• ClinicalTrials.gov Identifier: NCT05211375
• Recruitment Status: Recruiting
• First Posted: January 27, 2022
• Last Update Posted: January 27, 2022
• Sponsor: Seoul National University Bundang Hospital
• Collaborators: Ajou University School of Medicine; The Catholic University of Korea; The Catholic University of Korea Eunpyeong St. Mary's Hospital; Ewha University Seoul Hospital; Seoul Metropolitan Boramae Hospital; Soonchunhyang University Hospital; Korea University
• Information provided by (Responsible Party): Young Suk Park, MD, Seoul National University Bundang Hospital

Tracking Information

• First Submitted Date: January 4, 2022
• First Posted Date: January 27, 2022
• Last Update Posted Date: January 27, 2022
• Actual Study Start Date: January 3, 2022
• Estimated Primary Completion Date: January 3, 2031 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 13, 2022)

Complete remission rate of type 2 diabetes [ Time Frame: 5 years after surgery ]

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

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: January 13, 2022)

• Complete remission rate of type 2 diabetes [ Time Frame: 1, 3, 10 years after surgery ]
  HbA1c <6% (or fasting blood glucose [FBG] <100 mg/dL) without using any diabetes medication
• Partial remission rate of type 2 diabetes [ Time Frame: 1, 3, 5, 10 years after surgery ]
  Definition of partial remission of diabetes: HbA1c of 6-6.4% (or FBG of 100-125 mg/dL) without using any diabetes medication
• Improvement rate of type 2 diabetes [ Time Frame: 1, 3, 5, 10 years after surgery ]
  Definition of improvement of diabetes: Significant reduction in HbA1c (or FBG) level or decrease in the number of diabetic drugs or stoppage of insulin that does not meet the definition of remission.
• Hypertension remission rate [ Time Frame: 1, 3, 5, 10 years after surgery ]
  Definition of complete remission of hypertension: Blood pressure (BP) <120/80 mmHg without taking BP medication Definition of partial remission of hypertension: BP of 120-140/80-89 mmHg without taking BP medication
• Hypertension improvement rate [ Time Frame: 1, 3, 5, 10 years after surgery ]
  Definition of improvement of hypertension: Decrease in the number or dose of BP medications or decreased BP while taking medication
• Hyperlipidemia remission rate [ Time Frame: 1, 3, 5, 10 years after surgery ]
  Definition of remission of hyperlipidemia: Normal lipid profile (triglyceride [TG] <150 mg/dL and low-density lipoprotein [LDL] of 129 mg/dL or less and high-density lipoprotein [HDL] of 40 mg/dL or above) without taking hyperlipidemic drugs
• Hyperlipidemia improvement rate [ Time Frame: 1, 3, 5, 10 years after surgery ]
  Definition of improvement of hyperlipidemia: Reduced number or dose of hyperlipidemic drugs or improved lipid profile while taking hyperlipidemic drugs
• Prevalence of GERD [ Time Frame: 1, 3, 5, 10 years after surgery ]
  Acid reflux symptoms and positive endoscopic findings (LA classification A or more)
• Trace element deficiency rate (iron, vitamin B12, folate, vitamin B1, vitamin D, copper [Cu], and zinc [Zn]) [ Time Frame: 1, 3, 5, 10 years after surgery ]
  Iron deficiency: ferritin <20 ng/mL or iron <50 mcg/dL Vitamin B12 deficiency: <200 pg/mL, vitamin B12 suboptimal: 200 - <400 pg/mL Folate deficiency: <10nmol/L (4.4ng/mL) Vitamin B1 deficiency: <2.36 mcg/dL Vitamin D deficiency: <20 mg/mL, vitamin D insufficiency: 20-<30 ng/mL Cu deficiency: <75 mcg/dL Zn deficiency: <70 mcg/dL in women, < 74 mcg/dL in men
• Changes in body weight [ Time Frame: 1, 3, 5, 10 years after surgery ]
  kilograms
• Changes in body composition [ Time Frame: 1, 3, 5, 10 years after surgery ]
  body fat percentage(%), body fat mass (kg), and muscle mass(kg)
• Changes in Quality of life [ Time Frame: 1, 3, 5, 10 years after surgery ]
  IWQOL-Lite, SF-12
• Early complication rate [ Time Frame: Early: within 30 days after surgery ]
• Late complication rate [ Time Frame: Late: later than 30 days after surgery ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

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

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

Detailed Description

Most Asian patients undergoing metabolic surgery for the treatment of T2DM have BMI as low as 30-35 kg/m2. If SG is performed for the treatment of T2DM in these patients, weight may decrease after the surgery; however, T2DM may recur after 6 months to 1 year. Therefore, it is difficult to find clinical studies on SG for metabolic surgery in Asians, and gastric bypass may be more appropriate as metabolic surgery. However, gastroscopy for the remnant stomach after gastric bypass is practically impossible. Therefore, gastric bypass may be a fatal drawback for East Asian patients with a high incidence of gastric cancer. In recent years, modified duodenal switch (SG with duodenojejunal bypass [DJB], which is defined as the procedure that makes jejunal bypass shorter than the traditional duodenal switch) is often performed as metabolic surgery, and studies on this surgical technique are being actively conducted in Japan.

SG with DJB has both effects of stomach restriction and foregut bypass. However, SG with DJB is more disadvantageous compared to SG alone in nutrient absorption after surgery. This is a natural result of bypassing the duodenum and proximal jejunum. Therefore, SG with DJB should not be performed when it is unnecessary, and it should be performed in patients who are expected to show significant improvement in T2DM. However, there is no existing guideline on which patients can receive SG with DJB or SG alone, and there are also no clinical studies on these aspects.

• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

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

Intervention

• Procedure: Duodenojejunal 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.
• Procedure: Sleeve 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.

Study Arms

• Active Comparator: SG group
  Patients undergoing sleeve gastrectomy
  Intervention: Procedure: Sleeve gastrectomy
• Experimental: DJB group
  Patients undergoing duodenojejunal bypass with sleeve gastrectomy
  Intervention: Procedure: Duodenojejunal bypass

Publications *

• 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.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: January 13, 2022): 130
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: January 3, 2036
• Estimated Primary Completion Date: January 3, 2031 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Young Suk Park; +82-10-8980-6094; youngsukmd@gmail.com

• Listed Location Countries: Korea, Republic of

Administrative Information

• NCT Number: NCT05211375
• Other Study ID Numbers: MEDUSA
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Young Suk Park, MD, Seoul National University Bundang Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Seoul National University Bundang Hospital
• Original Study Sponsor: Same as current

Collaborators

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

Investigators

• Principal Investigator: Young Suk Park; Seoul National University Bundang Hospital

• PRS Account: Seoul National University Bundang Hospital
• Verification Date: January 2022