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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006192
Receipt No. R000007317
Scientific Title Oral choline tolerance test for nonalcoholic steatohepatitis as non-invasive diagnostic method
Date of disclosure of the study information 2011/08/18
Last modified on 2012/07/08

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Basic information
Public title Oral choline tolerance test for nonalcoholic steatohepatitis as non-invasive diagnostic method
Acronym Oral choline tolerance test for nonalcoholic steatohepatitis
Scientific Title Oral choline tolerance test for nonalcoholic steatohepatitis as non-invasive diagnostic method
Scientific Title:Acronym Oral choline tolerance test for nonalcoholic steatohepatitis
Region
Japan

Condition
Condition patients with nonalcoholic fatty liver disease
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Although a liver biopsy is presently recognized as the only reliable method of strictly distinguishing nonalcoholic steatohepatitis (NASH) from simple steatosis, this procedure is generally very invasive, expensive and may result in a sampling error.Thus, a non-invasive method for the diagnosis of NASH is needed. In the present study, we evaluate the utility and safety of the oral choline tolerance test for the diagnosis of NASH as an non-invasive method.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes Comparison of the plasma free choline levels of fasting and 1-h to 4-h samples with the diagnosis obtained by the liver biopsy
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Medicine
Interventions/Control_1 The subjects received the oral administration ofcholine (260 mg) under fasting conditions over 12 hours, following that 1-h to 4-h samples (plasma) are obtained.
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 and Female
Key inclusion criteria a.Obtaining informed consent
b.Diagnosis as nonalcoholic fatty liver disease
Key exclusion criteria a.HBs Ag(+) or HCV Ab(+)
b.AMA(+)
c.Alcohol consumption more than 20 g ethanol/day.
d.The patient who has possibility of other liver diseases
e.Woman who are pregnant or with a possibility of pregnancy
f.Renal dysfunction
g.Heart failure
h.Drug allergy
i.Inadequate ot entry to this study
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Atsushi Nakajima
Organization Yokohama City University Graduate School of Medicine
Division name Division of Gastroenterology
Zip code
Address 3-9 Fukuura, Kanazawa-ku, Yokohama, Japan
TEL 045-787-2640
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kento Imajo
Organization Yokohama City University Graduate School of Medicine
Division name Division of Gastroenterology
Zip code
Address 3-9 Fukuura, Kanazawa-ku, Yokohama, Japan
TEL 045-787-2640
Homepage URL
Email

Sponsor
Institute Division of Gastroenterology, Yokohama City University Graduate School of Medicine
Institute
Department

Funding Source
Organization Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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
2011 Year 08 Month 18 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 Completed
Date of protocol fixation
2011 Year 03 Month 30 Day
Date of IRB
Anticipated trial start date
2011 Year 04 Month 01 Day
Last follow-up date
2012 Year 06 Month 01 Day
Date of closure to data entry
2012 Year 06 Month 01 Day
Date trial data considered complete
2012 Year 06 Month 01 Day
Date analysis concluded
2012 Year 07 Month 01 Day

Other
Other related information

Management information
Registered date
2011 Year 08 Month 18 Day
Last modified on
2012 Year 07 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007317

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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