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

Clinical relevance of microalbuminuria and intra-renal RAS in metabolic sydrome patients. - Effect of olmesartan on microalbuminuria and intrarenal RAS - - A multicenter study on the effect of olmesartan on intrarenal RAS in metabolic syndrome patients.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001030

Enrollment

100

Registered

2008-02-13

Start date

2008-01-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic syndrome with hypertension

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) BMI >=25, or waist circumference >= 85 cm (Male), >= 90 cm (Female) 2) SBP >= 130 mmHg or DBP >= 85 mmHg In addition to above criteria, at least one criterion (below) is needed 1) TG >= 150 mg/dL and/or HDL <= 40 mg/dL 2) FBS >= 110 mg/dL

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Japan

Contacts

Public ContactHirofumi Hitomi

Kagawa University, Faculty of Medicine Department of Cardiorenal and Cerebrovascular Medicine

hitomi@kms.ac.jp087-891-5111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026