UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039857 |
|---|---|
| Receipt number | R000045455 |
| Scientific Title | Body muscle-to-fat ratio rather than fat-to-muscle ratio significantly and linearly correlated with the measure of insulin resistance in patients with type 2 |
| Date of disclosure of the study information | 2020/12/31 |
| Last modified on | 2020/03/18 09:04:14 |
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Basic information
Public title
Body muscle-to-fat ratio rather than fat-to-muscle ratio significantly and linearly correlated with the measure of insulin resistance in patients with type 2 diabetes
Acronym
Body muscle-to-fat ratio rather than fat-to-muscle ratio significantly and linearly correlated with the measure of insulin resistance
Scientific Title
Body muscle-to-fat ratio rather than fat-to-muscle ratio significantly and linearly correlated with the measure of insulin resistance in patients with type 2
Scientific Title:Acronym
Body muscle-to-fat ratio rather than fat-to-muscle ratio significantly and linearly correlated with the measure of insulin resistance
Region
| Japan |
Condition
Condition
untreated type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We test that BMFR rather than FMR could more quantitatively and accurately reflect each patients condition of insulin resistance in patients with untreated T2DM.
Basic objectives2
Others
Basic objectives -Others
We test that BMFR rather than FMR could more approximation with M / I value
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Approximation with M / I value
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Continuous untreated type 2 diabes mellitus patients with simultaneous body composition analysis and hyperinsulinemic-euglycemic clamp examinations
Key exclusion criteria
Untestable patients, ketoacidosis, infections
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Noboru |
| Middle name | |
| Last name | Kurinami |
Organization
Jinnouchi Hospital
Division name
Internal medicine
Zip code
862-0976
Address
6-2-3, Kuhonji, Kumamoto Shi Chuo Ku, Kumamoto Ken, Japan
TEL
0963630011
kurinami@jinnouchi.or.jp
Public contact
Name of contact person
| 1st name | Noboru |
| Middle name | |
| Last name | Kurinami |
Organization
Jinnouchi Hospital
Division name
Internal medicine
Zip code
862-0976
Address
6-2-3, Kuhonji, Kumamoto Shi Chuo Ku, Kumamoto Ken, Japan
TEL
0963630011
Homepage URL
kurinami@jinnouchi.or.jp
Sponsor or person
Institute
Jinnouchi Hospital
Institute
Department
Personal name
Funding Source
Organization
Jinnouchi Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Jinnouchi Hospital
Address
6-2-3, Kuhonji, Kumamoto Shi Chuo Ku, Kumamoto Ken, Japan
Tel
0963630011
kurinami@jinnouchi.or.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
| 2020 | Year | 12 | Month | 31 | 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
118
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
| 2014 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 17 | Day |
Anticipated trial start date
| 2014 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
non
Management information
Registered date
| 2020 | Year | 03 | Month | 18 | Day |
Last modified on
| 2020 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045455
