UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Epidemiological Assessment of NAFLD and Efficacy Evaluation of Nutritional and Exercise Intervention for NASH
Title of the study (Brief title)	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	Takeshi Suda
Organization	Niigata University Medical and Dental Hospital
Division name	Division of Gastroenterology & Hepatology
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	Kenya Kamimura
Organization	Niigata University Graduate School of Medical and Dental Sciences
Division name	Division of Gastroenterology & Hepatology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 09 Month 20 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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