UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006368
Receipt number 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 20:13:02

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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 or person

Institute

Niigata Hepatocellular Carcinoma Therapy Study Group

Institute

Department

Personal name



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

Value
https://center6.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