UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021519 |
|---|---|
| Receipt number | R000024812 |
| Scientific Title | Risk factor for hepatic fibrosis in men with type 2 diabetes |
| Date of disclosure of the study information | 2016/03/17 |
| Last modified on | 2016/03/17 17:57:06 |
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Basic information
Public title
Risk factor for hepatic fibrosis in men with type 2 diabetes
Acronym
Risk factor for hepatic fibrosis
Scientific Title
Risk factor for hepatic fibrosis in men with type 2 diabetes
Scientific Title:Acronym
Risk factor for hepatic fibrosis
Region
| Japan |
Condition
Condition
type 2 diabetes mellitus
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate the risk factors for hepatic fibrosis in men with type 2 diabetes
Basic objectives2
Others
Basic objectives -Others
usefulness
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Identify the risk factor for a hepatic fibrosis index calculated with results of examination on admission for diabetes treatment
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
| Not applicable |
Gender
Male
Key inclusion criteria
men with type 2 diabetes
Key exclusion criteria
1.type 1 diabetes or other type diabetes
2.more than 20g/day of alcohol consumption
3.positive for HBsAg or anti-HCV
4.patient with any other liver disease, such as other viral hepatitis, autoimmune hepatitis, or primary biliary cirrhosis
Target sample size
193
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shozo Miyauchi |
Organization
Uwajima City Hospital
Division name
Department of Internal Medicine
Zip code
Address
Uwajima city, Ehime, Japan
TEL
0895251111
syozo@uwajima-mh.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shozo Miyauchi |
Organization
Uwajima City Hospital
Division name
Department of Internal Medicine
Zip code
Address
Uwajima City, Ehime, Japan
TEL
0895251111
Homepage URL
syozo@uwajima-mh.jp
Sponsor or person
Institute
Uwajima City Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
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
| 2016 | Year | 03 | Month | 17 | 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
No longer recruiting
Date of protocol fixation
| 2013 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | Month | 17 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We reviewed the medical records of Japanese men with type 2 diabetes, who hospitalized in Uwajima City Hospital between March 2013 and December 2015.
We calculated an index of a hepatic fibrosis, and investigated risk factors for hepatic fibrosis.
Management information
Registered date
| 2016 | Year | 03 | Month | 17 | Day |
Last modified on
| 2016 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024812
