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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006368
Receipt No. R000007558
Scientific Title Epidemiological Assessment of NAFLD and Efficacy Evaluation of Nutritional and Exercise Intervention for NASH
Date of disclosure of the study information 2011/09/20
Last modified on 2017/04/01

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Basic information
Public title Epidemiological Assessment of NAFLD
and
Efficacy Evaluation of Nutritional and Exercise Intervention for NASH
Acronym Epidemiology of NAFLD and non-pharmacological intervention for NASH
Scientific Title Epidemiological Assessment of NAFLD
and
Efficacy Evaluation of Nutritional and Exercise Intervention for NASH
Scientific Title:Acronym Epidemiology of NAFLD and non-pharmacological intervention for NASH
Region
Japan

Condition
Condition Nonalcohol steatohepatitis
Classification by specialty
Medicine in general Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study aims to clarify the morbidity of non-alcoholic fatty liver diseases and the efficacy of non-pharmaceutical intervention on non-alcoholic steatohepatitis.
Basic objectives2 Others
Basic objectives -Others This study also focuses on the significance in NASH managements to measure shear wave velocity in the liver by implementing acoustic radiation force impulse, to define a stiffness of the carotid arterial wall, and to quantify APM2 gene products in the plasma.
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes A year after the first evaluation
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 If a case desired, non-pharmaceutical intervention is planned in the first 30 cases, which showed an abnormal study in one or more of liver stiffness, rigidity of carotid artery or serum fibrosis markers. Nutritional counseling and exercise therapy are conducted once a month or 2-months.
Interventions/Control_2 No intervention
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. No medical history in terms of chronic liver damage.
2. All of AST, ALT and GTP show abnormal values.
3. None of positive reaction for HBsAg, anti-HCV, AMA or ANA.
4. It is possible to be followed for a year.
5. A written informed consent from a patient himself/herself.
Key exclusion criteria For the people to start an exercise training

1. A pulse oximeter revealed oxygen saturation less than 95% at rest.
2. Abnormality in a 12-lead electrocardiogram at rest.
3. A doctor judged to be an improper case for this study.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takeshi Suda
Organization Niigata University Medical and Dental Hospital
Division name Division of Gastroenterology & Hepatology
Zip code
Address 1-754 Asahi-machi, Chuo-ku, Niigata, Niigata 951-8122, Japan
TEL 025-227-2207
Email tspitt@med.niigta-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kenya Kamimura
Organization Niigata University Graduate School of Medical and Dental Sciences
Division name Division of Gastroenterology & Hepatology
Zip code
Address 1-754 Asahi-machi, Chuo-ku, Niigata, Niigata 951-8122, Japan
TEL 025-227-2207
Homepage URL
Email tspitt@med.niigta-u.ac.jp

Sponsor
Institute Niigata Hepatocellular Carcinoma Therapy Study Group
Institute
Department

Funding Source
Organization Non
Organization
Division
Category of Funding Organization Self funding
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 1) 新潟大学大学院医歯学総合研究科 消化器内科学分野
2) 済生会新潟第二病院 消化器内科
3) 新潟市民病院 消化器内科
4) 新潟県労働衛生医学協会

Other administrative information
Date of disclosure of the study information
2011 Year 09 Month 20 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 09 Month 20 Day
Date of IRB
Anticipated trial start date
2011 Year 10 Month 01 Day
Last follow-up date
2015 Year 03 Month 01 Day
Date of closure to data entry
2015 Year 09 Month 01 Day
Date trial data considered complete
2016 Year 03 Month 01 Day
Date analysis concluded
2016 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2011 Year 09 Month 18 Day
Last modified on
2017 Year 04 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007558

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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