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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000003044
Receipt No. R000002844
Scientific Title Effect of Diet and Exercise Program for Chronic Hepatitis C with Insulin Resistance - Impact on liver function and virological response to Pegylated Interferon alpha-2b/Ribavirin-
Date of disclosure of the study information 2010/01/15
Last modified on 2015/01/15

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Basic information
Public title Effect of Diet and Exercise Program for Chronic Hepatitis C with Insulin Resistance - Impact on liver function and virological response to Pegylated Interferon alpha-2b/Ribavirin-
Acronym Effect of Diet and Exercise Program for Chronic Hepatitis C with Insulin Resistance (EPOCH)
Scientific Title Effect of Diet and Exercise Program for Chronic Hepatitis C with Insulin Resistance - Impact on liver function and virological response to Pegylated Interferon alpha-2b/Ribavirin-
Scientific Title:Acronym Effect of Diet and Exercise Program for Chronic Hepatitis C with Insulin Resistance (EPOCH)
Region
Japan

Condition
Condition Chronic hepatitis C
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to elucidate whether improvement of insulin resistance through diet and exercise intervention influenced liver function and virological response to pegylated interferon / ribavirin in chronic hepatitis C patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes (1) the degree of improvement in liver function
(2) the virological responce rate
Key secondary outcomes (1) the degree of improvement in HOMA-IR
(2) the change of body weight and waist circumference

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 Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Patients undergo the following dietary and exercise intervention for more than 3 months.
Diet therapy: Nutritional education by dietitian. Record of diet diary.
Exercise therapy: Instruction based on "exercise guide 2006" publishing by Ministry of Health, Labour and Welfare in Japan. Record of exercise diary.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients satisfying all the below are eligible.
(1)Chronic hepatitis C
(2)HCV genotype 1b or 2 with high viral load (5.0 or >5.0 logIU/mL)
(3)Insulin resistance (HOMA-IR 2 or >2)
Key exclusion criteria (1)pregnancy, its possibility or lactation
(2)hypersensitivity to IFN, pegylated IFN or ribavirin
(3)uncontrollable cardiac disease
(4)hemoglobinopathy
(5)creatinine clearance less than 50 mL/min
(6)severe mental illnesses such as depression or past history
(7)decompensated liver disease
(8)autoimmune hepatitis
(9)taking medication for DM or poor control of blood glucose levels
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshihiko Mizuta
Organization Saga Medical School
Division name Department of Internal Medicine
Zip code
Address 5-1-1 Nabeshima, Saga, Japan
TEL 0952-34-2362
Email mizutat@cc.saga-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yukie Watanabe
Organization Saga Medical School
Division name Division of Hepatology, Diabetology & Endocrinology
Zip code
Address 5-1-1 Nabeshima, Saga, Japan
TEL 0952-34-2362
Homepage URL
Email watanab2@cc.saga-u.ac.jp

Sponsor
Institute Saga Medical School
Institute
Department

Funding Source
Organization Department of Iinternal Medicine, Saga Medical School
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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 佐賀大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2010 Year 01 Month 15 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 No longer recruiting
Date of protocol fixation
2007 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2007 Year 06 Month 01 Day
Last follow-up date
2011 Year 03 Month 01 Day
Date of closure to data entry
2011 Year 05 Month 01 Day
Date trial data considered complete
2011 Year 07 Month 01 Day
Date analysis concluded
2011 Year 09 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 01 Month 15 Day
Last modified on
2015 Year 01 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002844

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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