UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003044 |
|---|---|
| Receipt number | 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 10:47:05 |
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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
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
watanab2@cc.saga-u.ac.jp
Sponsor or person
Institute
Saga Medical School
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002844
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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