Effects of branched-chain amino acid (Livact) on glucose tolerance in patients with chronic hepatitis C

UMIN ID: UMIN000001093

Registered date:21/03/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Chronic hepatitis C with insulin resistance
• Date of first enrollment: 2008/06/01
• Target sample size: 30
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

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.

Outcome(s)

• Primary Outcome: Changes in glucose tolerance and insulin sensitivity
• Secondary Outcome: Blood biochemistry and nutritional assessment

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude 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.

Related Information

• Primary Sponsor: Department of Disease Control and Homeostasis, Kanazawa University Graduate School of Medical Science
• Source(s) of Monetary Support: AJINOMOTO PHARMA Co., Ltd.