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


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 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


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

Value
https://center6.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