Therapeutic efficacy of olmesartan, telmisartan and amlodipine to compare with histologic improvement and addciation about AGTR1 gene polymorphisms in subjects with nonalcoholic steatohepatitis (NASH); randomized open-labeled prospective study.

UMIN ID: UMIN000001587

Registered date:25/12/2008

Basic Information

• Health condition(s) or Problem(s) studied: Non-alcoholic steatohepatitis
• Date of first enrollment: 2008/12/01
• Target sample size: 60
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

administration of olmesartan (40mg daily) in 24 weeks.
administration of telmisartan (40mg daily) in 24 weeks.
administration of amlodipine (7.5mg daily) in 24 weeks.

Outcome(s)

• Primary Outcome: Before and after 6 months of medication to nonalcoholic statohepatitis (NASH) patients, we assessed liver lipid-metabolite alteration for use minute lipid analyzer: LipoSEARCH, hepatic histologic features,and AGTR1 gene polymorphisms.
• Secondary Outcome: To measure the factors about NASH progressive marker as glucose and lipid metabolite, oxidative stress, visceral/subcutaneous fat area,liver TG content.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: 1)The patient with diabetes mellitus(HbA1c>6.2) 2) contraction of renal artery. 3) The criteria for exclusion from participation in the study: history of hepatic disease, such as chronic hepatitis C or concurrent active hepatitis B (serum positive for hepatitis B surface antigen), autoimmune hepatitis, primary biliary cirrhosis (PBC), sclerosing cholangitis, hemochromatosis, wilsons disease, and current or past consumption of more than 20g of alcohol daily. 4) an anamnesis of drug allergy to use.

Related Information

• Primary Sponsor: Yokohama City University Hospital
• Source(s) of Monetary Support: none