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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000009841
Receipt No. R000011533
Scientific Title Exploratory Cross-sectional Study of Associations between Fatty Acid Metabolism Scintigraphy (123I-BMIPP test) in the Liver of Nonalcoholic Fatty Liver Disease (NAFLD) Patients and Serum Biomarkers and the Degree of Progression of NAFLD Pathology
Date of disclosure of the study information 2013/02/01
Last modified on 2018/10/02

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Basic information
Public title Exploratory Cross-sectional Study of Associations between Fatty Acid Metabolism Scintigraphy (123I-BMIPP test) in the Liver of Nonalcoholic Fatty Liver Disease (NAFLD) Patients and Serum Biomarkers and the Degree of Progression of NAFLD Pathology
Acronym Exploratory Cross-sectional Study of Associations between Fatty Acid Metabolism Scintigraphy (123I-BMIPP test) in the Liver of Nonalcoholic Fatty Liver Disease (NAFLD) Patients and Serum Biomarkers and the Degree of Progression of NAFLD Pathology
Scientific Title Exploratory Cross-sectional Study of Associations between Fatty Acid Metabolism Scintigraphy (123I-BMIPP test) in the Liver of Nonalcoholic Fatty Liver Disease (NAFLD) Patients and Serum Biomarkers and the Degree of Progression of NAFLD Pathology
Scientific Title:Acronym Exploratory Cross-sectional Study of Associations between Fatty Acid Metabolism Scintigraphy (123I-BMIPP test) in the Liver of Nonalcoholic Fatty Liver Disease (NAFLD) Patients and Serum Biomarkers and the Degree of Progression of NAFLD Pathology
Region
Japan

Condition
Condition nonalcoholic fatty liver disease
Classification by specialty
Hepato-biliary-pancreatic medicine Endocrinology and Metabolism Radiology
Laboratory medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We will explore associations among the degree of pathological progression in the liver of NAFLD patients, BMIPP uptake in the liver by fatty acid scintigraphy, serum markers and several factors associated with lipid metabolism in the liver.
Basic objectives2 Others
Basic objectives -Others We will explore associations among the degree of pathological progression in the liver of NAFLD patients, BMIPP uptake in the liver by fatty acid scintigraphy, serum markers and several factors associated with lipid metabolism in the liver.
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes We will conduct this study by performing fatty acid scintigraphy in NAFLD patients grouped according to the degree of histopathological progression in the liver and make comparisons between the degrees of BMIPP uptake in the various groups.
Key secondary outcomes We will comprehensively analyze each factor involved in fatty acid metabolism in each group by using blood serum collected in the fasting state, after a meal, and during fatty acid scintigraphy, and liver tissue. Then we assess their relationships with the disease status.

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Medicine Device,equipment
Interventions/Control_1 We will perform fatty acid scintigraphy (123I-BMIPP test).
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
75 years-old >
Gender Male and Female
Key inclusion criteria NAFLD patients
Patients with a pathological diagnosis of NAFLD based on a liver biopsy within the past 8 weeks

Patients from whom consent has been obtained to participate in this study, which has been approved by the ethics committee.
Key exclusion criteria a. Patients who have any other liver disease, such as chronic hepatitis C, chronic hepatitis B (HBs-Ag-positive patients), autoimmune hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, &#61537;1-antitrypsin deficiency, Wilson disease, or alcohol-related liver disease
b. Patients who have a serious hepatic dysfunction, liver failure (encephalopathy, ascites, ruptured varices, or hyperbilirubinemia)
c. Patients who have a serious renal dysfunction
d. Patients who have a serious cardiopulmonary dysfunction
e. Pregnant women, parturient women, breast-feeding women
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuichi Nozaki
Organization National Center for Global Health and Medicine
Division name Department of Gastroenterology
Zip code
Address 1-21-1 Toyama, Shinjuku-ku, Tokyo
TEL 03-3202-7181
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yuichi Nozaki
Organization National Center for Global Health and Medicine
Division name Department of Gastroenterology
Zip code
Address 1-21-1 Toyama, Shinjuku-ku, Tokyo
TEL 03-3202-7181
Homepage URL
Email

Sponsor
Institute National Center for Global Health and Medicine, Department of Gastroenterology
Institute
Department

Funding Source
Organization National Center for Global Health and Medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Kochi University, Department of Gastroenterology
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 国立国際医療研究センター(東京都)

Other administrative information
Date of disclosure of the study information
2013 Year 02 Month 01 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 Terminated
Date of protocol fixation
2012 Year 12 Month 26 Day
Date of IRB
Anticipated trial start date
2013 Year 02 Month 01 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 22 Day
Last modified on
2018 Year 10 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011533

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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