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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000009899
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Chiba University Graduate School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011599

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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