UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009899 |
|---|---|
| Receipt number | R000011599 |
| Scientific Title | Relationship between insulin resistance and portal hemodynamics with cirrhosis |
| Date of disclosure of the study information | 2013/01/31 |
| Last modified on | 2013/02/03 08:44:54 |
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Basic information
Public title
Relationship between insulin resistance and portal hemodynamics with cirrhosis
Acronym
Insulin resistance in portal hypertension
Scientific Title
Relationship between insulin resistance and portal hemodynamics with cirrhosis
Scientific Title:Acronym
Insulin resistance in portal hypertension
Region
| Japan |
Condition
Condition
Cirrhosis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the pathophysiology and clinical significance of insulin resistance in portal hypertension
Basic objectives2
Others
Basic objectives -Others
Clarification of disease
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
HOMA-IR with respect to the development of collateral vessels
Key secondary outcomes
Relationship between peripheral/post sinusoidal HOMA-IR and portal hemodynamics/liver function reserve
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
Hepatic angiography
Interventions/Control_2
Color Doppler ultrasound examination
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 and Female
Key inclusion criteria
Patients with cirrhosis
Key exclusion criteria
Patients with the vascular abnormalities, such as portal thrombosis, arterio-portal communication
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hitoshi Maruyama |
Organization
Chiba University Graduate School of Medicine
Division name
Gastroenterology and Hepatology
Zip code
Address
1-8-1, Inohana, Chuou-ku, Chiba, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Chiba University Graduate School of Medicine
Division name
Gastroenterology and Hepatology
Zip code
Address
1-8-1, Inohana, Chuou-ku, Chiba, Japan
TEL
Homepage URL
Sponsor or person
Institute
Chiba University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 01 | 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
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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 12 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 01 | Month | 31 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 01 | Month | 29 | Day |
Last modified on
| 2013 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011599
