A multicenter observational study of clinical relevance of microalbuminuria and intra-renal RAS in type 2 diabetes.

A multicenter observational study of clinical relevance of microalbuminuria and intra-renal RAS in type 2 diabetes. - Clinical relevance of diabetic complications and intra-renal RAS in type 2 diabetes.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000001886

Enrollment

300

Registered

2009-04-14

Start date

2009-04-01

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

Type 2 Diabetes Mellitus

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Albuminuria <=30 mg/gCr 2) Diabetes mellitus - FBS >= 126 mg/dL - 75g OGTT (2 hours) >= 200 mg/dL - PPG >= 200 mg/dL 3) BP <= 130/80 mmHg 4) Patients who have not been treated with ARB, ACEI or MR blocker within 4 weeks

Exclusion criteria

Exclusion criteria: 1) Type 1 diabetes mellitus 2) Pregnancy 3) Severe renal disease (Proteinuria, CCr<50 mL/min, sCr >= 1.5 mg/dL) 4) Severe hepatic disease (GOT >= 150 IU or GPT >= 150 IU) 5) Endocrine disease 6) Patients with malignant tumor 7) Patients inadequate for the study

Design outcomes

Primary

Measure	Time frame
1) AGT (urine and serum): 0, 6, 12, 18, 24, 30 and 36 months 2) Albumin (urine): 0, 6, 12, 18, 24, 30 and 36 months	—

Secondary

Measure	Time frame
1) BP: 0, 6, 12, 18, 24, 30 and 36 months 2) BW, BMI, waist circumference:0, 6, 12, 18, 24, 30 and 36 months 3) FBS, insulin, HbA1c: 0, 6, 12, 18, 24, 30 and 36 months 4) PRA, Aldosterone: 0, 12, 24 and 36 months 5) T-chol, LDL-chol, HDL-chol, TG: 0, 12, 24 and 36 months 6) Cr, BUN, UA: 0, 6, 12, 18, 24, 30 and 36 months 7) Transferrin, type IV collagen (urine): 0, 6, 12, 18, 24, 30 and 36 months 8) Cardiovascular events: 0-36 months 9) Insulin sensitivity: 0, 12, 24 and 36 months 10) hsCRP: 0, 12, 24 and 36 months	—

Measure

Time frame

1) BP: 0, 6, 12, 18, 24, 30 and 36 months 2) BW, BMI, waist circumference:0, 6, 12, 18, 24, 30 and 36 months 3) FBS, insulin, HbA1c: 0, 6, 12, 18, 24, 30 and 36 months 4) PRA, Aldosterone: 0, 12, 24 and 36 months 5) T-chol, LDL-chol, HDL-chol, TG: 0, 12, 24 and 36 months 6) Cr, BUN, UA: 0, 6, 12, 18, 24, 30 and 36 months 7) Transferrin, type IV collagen (urine): 0, 6, 12, 18, 24, 30 and 36 months 8) Cardiovascular events: 0-36 months 9) Insulin sensitivity: 0, 12, 24 and 36 months 10) hsCRP: 0, 12, 24 and 36 months

—

Countries

Japan

Contacts

Public ContactHirofumi Hitomi

Kagawa University, Faculty of Medicine Department of Pharmacology

hitomi@kms.ac.jp087-891-5111

Outcome results