Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Comparisons of Metabolic Effect of Sleeve Gastrectomy With Duodenojejunal Bypass and Sleeve Gastrectomy (MEDUSA): A Multicenter Randomized Controlled Trial
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
Status | Recruiting |
Enrollment | 130 |
Est. completion date | January 3, 2036 |
Est. primary completion date | January 3, 2031 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Seoul National University Bundang Hospital | Seongnam-si |
Lead Sponsor | Collaborator |
---|---|
Seoul National University Bundang Hospital | Ajou University School of Medicine, Ewha University Seoul Hospital, Korea University, Seoul Metropolitan Boramae Hospital, Soonchunhyang University Hospital, The Catholic University of Korea, The Catholic University of Korea Eunpyeong St. Mary's Hospital |
Korea, Republic of,
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. — View 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. Review. — View Citation
Hofsø D, Fatima F, Borgeraas H, Birkeland KI, Gulseth HL, Hertel JK, Johnson LK, Lindberg M, Nordstrand N, Cvancarova Småstuen M, Stefanovski D, Svanevik M, Gretland Valderhaug T, Sandbu R, Hjelmesæth 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Complete remission rate of type 2 diabetes | HbA1c <6% (or fasting blood glucose [FBG] <100 mg/dL) without using any diabetes medication | 1, 3, 10 years after surgery | |
Secondary | Partial remission rate of type 2 diabetes | Definition of partial remission of diabetes: HbA1c of 6-6.4% (or FBG of 100-125 mg/dL) without using any diabetes medication | 1, 3, 5, 10 years after surgery | |
Secondary | Improvement rate of type 2 diabetes | 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. | 1, 3, 5, 10 years after surgery | |
Secondary | Hypertension remission rate | 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 | 1, 3, 5, 10 years after surgery | |
Secondary | Hypertension improvement rate | Definition of improvement of hypertension: Decrease in the number or dose of BP medications or decreased BP while taking medication | 1, 3, 5, 10 years after surgery | |
Secondary | Hyperlipidemia remission rate | 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 | 1, 3, 5, 10 years after surgery | |
Secondary | Hyperlipidemia improvement rate | Definition of improvement of hyperlipidemia: Reduced number or dose of hyperlipidemic drugs or improved lipid profile while taking hyperlipidemic drugs | 1, 3, 5, 10 years after surgery | |
Secondary | Prevalence of GERD | Acid reflux symptoms and positive endoscopic findings (LA classification A or more) | 1, 3, 5, 10 years after surgery | |
Secondary | Trace element deficiency rate (iron, vitamin B12, folate, vitamin B1, vitamin D, copper [Cu], and zinc [Zn]) | 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 | 1, 3, 5, 10 years after surgery | |
Secondary | Changes in body weight | kilograms | 1, 3, 5, 10 years after surgery | |
Secondary | Changes in body composition | body fat percentage(%), body fat mass (kg), and muscle mass(kg) | 1, 3, 5, 10 years after surgery | |
Secondary | Changes in Quality of life | IWQOL-Lite, SF-12 | 1, 3, 5, 10 years after surgery | |
Secondary | Early complication rate | Early: within 30 days after surgery | ||
Secondary | Late complication rate | Late: later than 30 days after surgery |
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