Clinical relevance of microalbuminuria and intra-renal RAS in metabolic sydrome patients. - Effect of olmesartan on microalbuminuria and intrarenal RAS
Phase 4
- Conditions
- Metabolic syndrome with hypertension
- Registration Number
- JPRN-UMIN000001030
- Lead Sponsor
- Kagawa University, Faculty of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
Not provided
Exclusion 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method 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