UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036802 |
|---|---|
| Receipt number | R000041879 |
| Scientific Title | The significance of the Fib-4 index measurement in a diabetic population |
| Date of disclosure of the study information | 2019/05/20 |
| Last modified on | 2019/05/15 12:06:57 |
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Basic information
Public title
The significance of the Fib-4 index measurement in a diabetic population
Acronym
The significance of the Fib-4 index measurement in a diabetic population
Scientific Title
The significance of the Fib-4 index measurement in a diabetic population
Scientific Title:Acronym
The significance of the Fib-4 index measurement in a diabetic population
Region
| Japan |
Condition
Condition
Diabetes or impaired glucose tolerance
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We retrospectively evaluated the association between Fib-4 index and arteriosclerosis related test value or clinical background and therapy with diabetic patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
the association between Fib-4 index and arteriosclerosis related test value
Key secondary outcomes
The predictability of Fib-4 index for identifying patients with/without carotid artery plaque is evaluated by receiver-operating-characteristic(ROC) curve analysis.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Measurements of Fib-4 index, intima-media thickness(IMT)through ultrasonography, and brachial-ankle pulse wave velocity(baPWV)
Type 1 diabetes, type 2 diabetes, or impaired glucose tolerance
Key exclusion criteria
Participation in the study is judged by the investigator or sub-investigator as inappropriate for any other reason
Target sample size
6673
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Osonoi |
Organization
Nakakinen Clinic
Division name
Director
Zip code
311-0113
Address
745-5 Nakadai, Naka-shi, Ibaraki
TEL
029-353-2800
k-ofuchi@kensei-kai.com
Public contact
Name of contact person
| 1st name | Kensuke |
| Middle name | |
| Last name | Ofuchi |
Organization
Nakakinen Clinic
Division name
Department of clinical research
Zip code
311-0113
Address
745-5 Nakadai, Naka-shi, Ibaraki
TEL
029-353-2800
Homepage URL
t-osonoi@kensei-kai.com
Sponsor or person
Institute
Nakakinen Clinic
Institute
Department
Personal name
Funding Source
Organization
Nakakinen Clinic
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
Nakakinen Clinic
Address
745-5 Nakadai, Naka-shi, Ibaraki
Tel
029-353-2800
k-ofuchi@kensei-kai.com
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
那珂記念クリニック（茨城県）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 05 | Month | 20 | 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
6673
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 | 11 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 26 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2019 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 05 | Month | 31 | Day |
Other
Other related information
Single facility retrospective observation study
Management information
Registered date
| 2019 | Year | 05 | Month | 20 | Day |
Last modified on
| 2019 | Year | 05 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041879
| Research Plan | |
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| 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 |
