Chronic hepatitis C with insulin resistance
Conditions
Interventions
Treated with LIVACT granules for 12 weeks, and thereafter treated without LIVACT for 12 weeks.
Treated without LIVACT granules for 12 weeks, and thereafter treated with LIVACT for 12 weeks.
Sponsors
Department of Disease Control and Homeostasis, Kanazawa University Graduate School of Medical Science
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in glucose tolerance and insulin sensitivity | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood biochemistry and nutritional assessment | — |
Countries
Japan
Contacts
Public ContactHitoshi Ando
Kanazawa University Graduate School of Medical Science Department of Disease Control and Homeostasis
Outcome results
None listed