UMIN-CTR Clinical Trial

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
Last 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
Email	k-ofuchi@kensei-kai.com

Public contact
1st 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
Email	t-osonoi@kensei-kai.com

Sponsor
Institute	Nakakinen Clinic
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041879