UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038432 |
|---|---|
| Receipt number | R000043792 |
| Scientific Title | Bariatric surgery vs intensive medical therapy in mildly obese Japanese patients with early onset type 2 diabetes mellitus |
| Date of disclosure of the study information | 2019/11/01 |
| Last modified on | 2020/04/29 14:30:01 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
y-seki@mcube.jp
Sponsor or person
Institute
Weight Loss and Metabolic Surgery Center, Yotsuya Medical Cube
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043792
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
