Clinical relevance of microalbuminuria and intra-renal RAS in metabolic sydrome patients. - Effect of olmesartan on microalbuminuria and intrarenal RAS -

UMIN ID: UMIN000001030

Registered date:13/02/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Metabolic syndrome with hypertension
• Date of first enrollment: 2008/01/01
• Target sample size: 100
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Olmesartan (5-20mg/day, 24 weeks)
Anti-hypertensive drugs except ARB, ACEI or diuretics (24 weeks)

Outcome(s)

• Primary Outcome: 1) AGT (urine and serum): 0, 12 and 24 weeks after treatment with olmesartan 2) albumin (urine): 0, 12 and 24 weeks after treatment with olmesartan
• Secondary Outcome: 1) BP: 0, 4, 8, 12, 16, 20 and 24 weeks after treatment with olmesartan 2) BW, BMI: 0, 12 and 24 weeks after treatment with olmesartan 3) waist circumference: 0, 12 and 24 weeks after treatment with olmesartan 4) FBS, insulin, HbA1c: 0, 12 and 24 weeks after treatment with olmesartan 5) PRA, Aldosterone: 0, 12 and 24 weeks after treatment with olmesartan 6) LDL-chol, HDL-chol, TG: 0, 12 and 24 weeks after treatment with olmesartan 7) gamma-GTP, ALT, AST: 0, 12 and 24 weeks after treatment with olmesartan 8) hsCRP, urinary L-FABP, urinary 8-OHdG, urinary TBARS: 0, 12 and 24 weeks after treatment with olmesartan 9) Cardiovascular events: 0-24 weeks after treatment with olmesartan

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 70years-old
• Gender: Male and Female
• Exclude criteria: 1) Pregnancy 2) Patient who has been treated with ARB, ACEI or diuretics within 4 weeks 3) Patient with diabetes mellitus who treats with anti-diabetic drugs 4) Severe hypertension (SBP >= 160 mmHg or DBP >= 110 mmHg) 5) Secondary hypertension 6) Severe renal disease (UACR>300 mg/g, CCr<30 mL/min, sCr >= 2.0 mg/dL) 7) Severe hepatic disease (GOT >= 150 IU or GPT >= 150 IU) 8) History of major cardiac or cerebrovascular events 9) Endocrine disease 10) Patients with malignant tumor 11) Patients inadequate for the study

Related Information

• Primary Sponsor: Kagawa University, Faculty of Medicine
• Source(s) of Monetary Support: None