UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033585 |
|---|---|
| Receipt number | R000038299 |
| Scientific Title | Gender specific cut-off values of BMFR for the Insulin resistance in Treatment naive T2DM |
| Date of disclosure of the study information | 2019/01/01 |
| Last modified on | 2018/08/01 11:21:09 |
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Basic information
Public title
Gender specific cut-off values of BMFR for the Insulin resistance in Treatment naive T2DM
Acronym
Gender specific cut-off values of BMFR for the Insulin resistance
Scientific Title
Gender specific cut-off values of BMFR for the Insulin resistance in Treatment naive T2DM
Scientific Title:Acronym
Gender specific cut-off values of BMFR for the Insulin resistance
Region
| Japan |
Condition
Condition
type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Gender specific cut-off values of BMFR for the Impaired Insulin sensitivity in Treatment naive T2DM.
Basic objectives2
Others
Basic objectives -Others
We diagnosed the presence of insulin sensitivity disorder by hyperinsulinemic-euglycemic clamp examination, and calculated the body muscle to fat ratio (BMFR)from the body composition analysis result by the bioelectrical impedance method.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
In patients with untreated type 2 diabetes, the presence of insulin sensitivity disorder diagnosed by hyperinsulinemic-euglycemic clamp examination, and the body muscle to fat ratio (BMFR) calculated from the body composition analysis result by the bioelectrical impedance method are compared and examined.
Key secondary outcomes
M/I ratio diagnosed by hyperinsulinemic-euglycemic clamp examination.
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
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with untreated type 2 diabetes mellitus
Key exclusion criteria
Diabetic ketoacidosis, Severe infection, Malignant disease, Examination impossible patient
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Noboru Kurinami |
Organization
jinnouchi Hosptal
Division name
Internal medicine
Zip code
Address
6-2-3, Kuhonji, Chuo-ku Kumamoto-shi, Kumamoto, 862-0976, Japan
TEL
096-363-0011
kurinami@jinnouchi.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Noboru Kurinami |
Organization
jinnouchi Hosptal
Division name
Internal medicine
Zip code
Address
6-2-3, Kuhonji, Chuo-ku Kumamoto-shi, Kumamoto, 862-0976, Japan
TEL
096-363-0011
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
Other
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
陣内病院（熊本県）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 01 | 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
Completed
Date of protocol fixation
| 2018 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
| 2018 | Year | 08 | Month | 07 | Day |
Date trial data considered complete
| 2018 | Year | 08 | Month | 08 | Day |
Date analysis concluded
| 2018 | Year | 08 | Month | 15 | Day |
Other
Other related information
Design name:
Single facility retrospective observation study
Management information
Registered date
| 2018 | Year | 08 | Month | 01 | Day |
Last modified on
| 2018 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038299
