UMIN-CTR Clinical Trial

Basic information
Public title	Bariatric surgery vs intensive medical therapy in mildly obese Japanese patients with early onset type 2 diabetes mellitus
Acronym	Bariatric surgery vs intensive medical therapy in mildly obese Japanese patients with early onset T2DM
Scientific Title	Bariatric surgery vs intensive medical therapy in mildly obese Japanese patients with early onset type 2 diabetes mellitus
Scientific Title:Acronym	Bariatric surgery vs intensive medical therapy in mildly obese Japanese patients with early onset T2DM
Region	Japan

Condition
Condition	Obesity, type 2 diabetes mellitus
Classification by specialty	Endocrinology and Metabolism Gastrointestinal surgery Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study will be the first RCT from Japan involving young-onset T2DM with mild obesity. We will determine the relative effectiveness of bariattric surgery in reducing diabetes and CVD risk factor. Best medical management (BMM) will include best available lifestyle modification focusing on weight loss and pharmacologic treatment for diabetes and other CVD risk factors.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The primary outcome will be assessed at 1 year, and will be a success rate of patients with HbA1c less than 6.5% without diabetes medication.
Key secondary outcomes	1. Changes in weight and BMI, waist circumference, HbA1c, fasting glucose, fasting insulin, systolic blood pressure, diastolic blood pressure, lipid profile (serum total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides) 2. Changes in urine microalbumin/creatinine ratio and resolution of co-morbid renal function illness. 3. Use of medications (as measured by dosages and cost) 4. Total cost of diabetes- and CVD-related health care 5. Measures from three surveys: Quality of life (SF-36). The surveys will be collected at the baseline, 6 months, and 12 months. 6. Mortality 7. Cardiovascular events (myocardial infarction, stroke, other serious CVD) 8. Complications from surgery

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Laparoscopic sleeve gastrectomy with duodenojejunal bypass (LSG-DJB)
Interventions/Control_2	Best medical management focusing on lifestyle modification and pharmacologic treatment
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	Not applicable
Age-upper limit	50 years-old >
Gender	Male and Female
Key inclusion criteria	1) Diagnosed with T2DM at the age of younger than 40 years old. 2) Under the active care of a doctor for at least 6 months prior to enrollment, and HbA1c more than 8%.0 % < HbA1c. 3) Duration of T2DM less than 10 years from diagnosis. 4) BMI 27.5-34.9 kg/m2 at eligibility visit. 5) Willingness to accept random assignment to either treatment group. 6) Willingness to comply with the follow-up protocol. 7) Written informed consent.
Key exclusion criteria	1) Cardiovascular event in the past 6 months. 2) Current evidence of congestive heart failure, angina pectoris, or symptomatic peripheral vascular disease. 3) Cardiac stress test indicating that surgery would not be safe. 4) Pulmonary embolus or thrombophlebitis in the past 6 months. 5) Cancer of any kind unless documented to be disease-free for 5 years. 6) Significant anemia (hemoglobin 1.0 g or more below normal range) or history of coagulopathy. 7) Serum creatinine less than 1.5 mg/dl. 8) Serum total bilirubin greater than the upper limit of normal, or alkaline phosphatase or ALT greater than twice the upper limit of normal. 9) History of stomach surgery, bile duct surgery, pancreatic surgery, splenectomy, or colon resection. 10) Gastric or duodenal ulcer in the past 6 months. 11) History of intra-abdominal sepsis. 12) Self-reported HIV-positive status, active tuberculosis, active malaria, chronic hepatitis B or C, cirrhosis, or inflammatory bowel disease. 13) Currently pregnant or nursing, or planning to become pregnant in the next 2 years. 14) History of alcohol or drug dependency in the past 5 years. 15) Active psychosocial or psychiatric problem that is likely to interfere with adherence to the protocol. 16) Presence of any chronic or debilitating disease that would make adherence to the protocol difficult. 17) 12-lead EKG indicating that surgery would not be safe. 18) Serum fasting c-peptide less than 1.0 ng/ml. 19) Exclusions may also be made at the discretion of the attending physician.
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Yosuke Middle name Last name Seki
Organization	Yotsuya Medical Cube
Division name	Weight Loss and Metabolic Surgery Center
Zip code	102-0084
Address	7-7 Nibancho, Chiyoda-ku, Tokyo, Japan
TEL	03-3261-0401
Email	y-seki@mcube.jp

Public contact
Name of contact person	1st name Yosuke Middle name Last name Seki
Organization	Yotsuya Medical Cube
Division name	Weight Loss and Metabolic Surgery Center
Zip code	102-0084
Address	7-7 Nibancho, Chiyoda-ku, Tokyo, Japan
TEL	03-3261-0401
Homepage URL
Email	y-seki@mcube.jp

Sponsor
Institute	Weight Loss and Metabolic Surgery Center, Yotsuya Medical Cube
Institute
Department

Funding Source
Organization	Daiwa Securities Health Foundation, Medtronic
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Division of Clinical Research, Yotsuya Medical Cube
Address	7-7 Nibancho, Chiyoda-ku, Tokyo, Japan
Tel	03-3261-0401
Email	h-satoh@mcube.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2019 Year 11 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2019 Year 11 Month 01 Day
Date of IRB	2019 Year 10 Month 30 Day
Anticipated trial start date	2019 Year 12 Month 01 Day
Last follow-up date	2023 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 10 Month 29 Day
Last modified on	2020 Year 04 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043792