Clinical trial NCT05211375: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Bariatric Surgery
Surgical Procedures, Operative
Asians
Keywords: Bariatric Surgery
Metabolic Surgery
Diabetes Remission
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
Collaborators: name: Ajou University School of Medicine
name: The Catholic University of Korea
name: The Catholic University of Korea Eunpyeong St. Mary's Hospital
name: Ewha University Seoul Hospital
name: Seoul Metropolitan Boramae Hospital
name: Soonchunhyang University Hospital
name: Korea University
First posted: 2022-01-27
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Complete remission rate of type 2 diabetes
timeFrame: 5 years after surgery
Secondary outcomes:
measure: Complete remission rate of type 2 diabetes
timeFrame: 1, 3, 10 years after surgery
measure: Partial remission rate of type 2 diabetes
timeFrame: 1, 3, 5, 10 years after surgery
measure: Improvement rate of type 2 diabetes
timeFrame: 1, 3, 5, 10 years after surgery
measure: Hypertension remission rate
timeFrame: 1, 3, 5, 10 years after surgery
measure: Hypertension improvement rate
timeFrame: 1, 3, 5, 10 years after surgery
measure: Hyperlipidemia remission rate
timeFrame: 1, 3, 5, 10 years after surgery
measure: Hyperlipidemia improvement rate
timeFrame: 1, 3, 5, 10 years after surgery
measure: Prevalence of GERD
timeFrame: 1, 3, 5, 10 years after surgery
measure: Trace element deficiency rate (iron, vitamin B12, folate, vitamin B1, vitamin D, copper [Cu], and zinc [Zn])
timeFrame: 1, 3, 5, 10 years after surgery
measure: Changes in body weight
timeFrame: 1, 3, 5, 10 years after surgery
measure: Changes in body composition
timeFrame: 1, 3, 5, 10 years after surgery
measure: Changes in Quality of life
timeFrame: 1, 3, 5, 10 years after surgery
measure: Early complication rate
timeFrame: Early: within 30 days after surgery
measure: Late complication rate
timeFrame: Late: later than 30 days after surgery
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Young Suk Park
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.