UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001093 |
|---|---|
| Receipt number | 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 09:40:22 |
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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
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
h-ando@jichi.ac.jp
Sponsor or person
Institute
Department of Disease Control and Homeostasis, Kanazawa University Graduate School of Medical Science
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001208
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