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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001093
Receipt No. R000001208
Scientific Title Effects of branched-chain amino acid (Livact) on glucose tolerance in patients with chronic hepatitis C
Date of disclosure of the study information 2008/03/21
Last modified on 2010/08/11

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Basic information
Public title Effects of branched-chain amino acid (Livact) on glucose tolerance in patients with chronic hepatitis C
Acronym Effects of branched-chain amino acid therapy on glucose tolerance in patients with chronic hepatitis C
Scientific Title Effects of branched-chain amino acid (Livact) on glucose tolerance in patients with chronic hepatitis C
Scientific Title:Acronym Effects of branched-chain amino acid therapy on glucose tolerance in patients with chronic hepatitis C
Region
Japan

Condition
Condition Chronic hepatitis C with insulin resistance
Classification by specialty
Hepato-biliary-pancreatic medicine Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effects of branched-chain amino acid (BCAA) therapy on glucose tolerance and insulin sensitivity in patients with chronic hepatitis C and insulin resistance.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase III

Assessment
Primary outcomes Changes in glucose tolerance and insulin sensitivity
Key secondary outcomes Blood biochemistry and nutritional assessment

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Treated with LIVACT granules for 12 weeks, and thereafter treated without LIVACT for 12 weeks.
Interventions/Control_2 Treated without LIVACT granules for 12 weeks, and thereafter treated with LIVACT for 12 weeks.
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 are eligible for this study if they meet all the following criteria:
1)Have a definitive diagnosis of hepatitis C virus-associated chronic hepatitis or hepatic cirrhosis.
2)Present with insulin resistance, as determined by a 10microU/mL or higher level of fasting immunoreactive insulin measured during the observation period.
4)An inpatient or an outpatient
3)Be capable of giving consent for participation in this study in writing.
Key exclusion criteria Patients will be excluded from the study if they meet any of the following criteria:
1) Have a continuous serum albumin level of 2.5 g/dL or less.
2) Treated with albumin preparations regularly (at least once weekly for one month or longer).
3) Have already received BCAA preparations within 4 weeks prior to enrolling in this study.
4) A status of coma rated as Grade III or higher due to hepatic encephalopathy.
5) A total bilirubin level of 3.0 mg/dL or higher.
6) Concurrent hepatocellular carcinoma, as determined by diagnostic imaging results.
7) Alcoholic cirrhosis and alcohol dependence.
8) High-risk esophageal aneurism probably requiring sclerotherapy in the near future.
9) Concurrent renal failure probably requiring dialysis therapy in the near future.
10) Congenital abnormality of branched-chain amino acid metabolism.
11) Poorly controlled diabetes with a fasting blood glucose level of 150 mg/dL or higher; or patients with diabetes treated with any of the following drugs: sulfonylureas, biguanides, tiazolidines, and insulins (except where only very-rapid-acting or rapid-acting insulin products are used).
12) Concomitant corticosteroid therapy.
13) Concomitant interferon therapy.
14) Those who are inadequate for this study as assessed by the investigators.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shuichi Kaneko
Organization Kanazawa University Graduate School of Medical Science
Division name Department of Disease Control and Homeostasis
Zip code
Address 13-1 Takara-machi, Kanazawa, Ishikawa, Japan
TEL 076-265-2233
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hitoshi Ando
Organization Kanazawa University Graduate School of Medical Science
Division name Department of Disease Control and Homeostasis
Zip code
Address 13-1 Takara-machi, Kanazawa, Ishikawa, Japan
TEL 076-265-2234
Homepage URL
Email h-ando@jichi.ac.jp

Sponsor
Institute Department of Disease Control and Homeostasis, Kanazawa University Graduate School of Medical Science
Institute
Department

Funding Source
Organization AJINOMOTO PHARMA Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
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

Other administrative information
Date of disclosure of the study information
2008 Year 03 Month 21 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2007 Year 10 Month 05 Day
Date of IRB
Anticipated trial start date
2008 Year 06 Month 01 Day
Last follow-up date
2009 Year 09 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2008 Year 03 Month 21 Day
Last modified on
2010 Year 08 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001208

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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