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-

UMIN ID: UMIN000003044

Registered date:15/01/2010

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: Chronic hepatitis C
• Date of first enrollment: 2007/06/01
• Target sample size: 40
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): 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.

Outcome(s)

• Primary Outcome: (1) the degree of improvement in liver function (2) the virological responce rate
• Secondary Outcome: (1) the degree of improvement in HOMA-IR (2) the change of body weight and waist circumference

Key inclusion & exclusion criteria

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

Related Information

• Primary Sponsor: Saga Medical School
• Source(s) of Monetary Support: Department of Iinternal Medicine, Saga Medical School