UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026921 |
|---|---|
| Receipt number | R000030855 |
| Scientific Title | Exploring ways to suppress manifestation of type 2 diabetes mellitus and coexist with fat |
| Date of disclosure of the study information | 2017/04/10 |
| Last modified on | 2022/10/14 09:24:04 |
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Basic information
Public title
Exploring ways to suppress manifestation of type 2 diabetes mellitus and coexist with fat
Acronym
Exploring ways to suppress manifestation of type 2 diabetes mellitus and coexist with fat
Scientific Title
Exploring ways to suppress manifestation of type 2 diabetes mellitus and coexist with fat
Scientific Title:Acronym
Exploring ways to suppress manifestation of type 2 diabetes mellitus and coexist with fat
Region
| Japan |
Condition
Condition
Type 2 Diabetes Mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we explore the characteristics and patterns of lipid accumulation in the two insulin target organs (liver and muscle) without causing insulin resistance, the predominant symptom of type 2 diabetes.
Basic objectives2
Others
Basic objectives -Others
To elucidate the characteristics regarding life style and gene expression of the patients who can preserve their insulin sensitivity
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Quantitative measure of intracellular lipid accumulation in each insulin target organ
2. Quantitative value of insulin sensitivity in each insulin target organ
3. Quantitative amount of whole-body fat and muscle mass, intraperitoneal adipose and subcutaneous fat
4. Information regarding patient's life style
5. Urine and blood test results
6. Gene expression profiling and hepatic histopathological evaluation
7. Measurement results of respiratory quotient
8. Other exploratory items
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
Clinical Examination
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who meet all of the following criteria are included in this study:
1. Female or male patients with fatty liver aged 20 to 70 years old, and possibly with fat accumulation in their muscle
2. Fatty liver with deviation enzyme, ALT over 30 IU/L at blood sampling
3. Patient who can go through the process of hepatic biopsy
4. Patients' HbA1c has to be below 10% if they are using glinide, alpha-glucosidase inhibitor, or a small amount of SU (Amaryl 2 mg or less)
5. Patients who can give their written consent to participant in this study
Key exclusion criteria
Patients who fall into any of the following criteria are excluded from participating in the study:
1. Patients with type 1 diabetes or secondary diabetes
2. Patients with moderate to severe renal function disease or at the terminal stage of renal failure (eGFR< 45mL/min/1.73m2)
3. Patients who had stroke or cerebral infarction within 12 weeks before giving their consent
4. Patients with myocardial infarction or angina pectoris in the past, or currently with atrial fibrillation
5. Patients with other conditions that the investigator/researcher thinks inappropriate for the study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoki Kumashiro |
Organization
Toho University Omori Medical Center
Division name
Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine
Zip code
Address
6-11-1 Omori-nishi, Ota-ku, Tokyo 143-8541
TEL
03-3762-4151
naoki.kumashiro@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoki Kumashiro |
Organization
Toho University Omori Medical Center
Division name
Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine
Zip code
Address
6-11-1 Omori-nishi, Ota-ku, Tokyo 143-8541
TEL
03-3762-4151
Homepage URL
naoki.kumashiro@med.toho-u.ac.jp
Sponsor or person
Institute
Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine, Toho University Omori Medical Center
Institute
Department
Personal name
Funding Source
Organization
Department of Internal Medicine (Omori), Toho University, and
The Ministry of Education, Culture, Sports, Science and Technology (MEXT)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2017 | Year | 04 | Month | 10 | 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
Completed
Date of protocol fixation
| 2017 | Year | 04 | Month | 03 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 10 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
From the perspectives of life style and gene expression, we attempt to elucidate the characteristics among those who can maintain their insulin sensitivity despite lipid accumulation in the insulin target organ (liver and/or muscle) for a year or longer.
In order for us to collect data about type 2 diabetic patients with fatty liver, we enroll 30 patients who are able to meet the inclusion criteria.
Management information
Registered date
| 2017 | Year | 04 | Month | 10 | Day |
Last modified on
| 2022 | Year | 10 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030855
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
