A prospective, time-series, multicenter study on the effect of telmisartan on intra-renal RAS in type 2 diabetes.
Phase 4
- Conditions
- Type 2 Diabetes Mellitus
- Registration Number
- JPRN-UMIN000001887
- 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
- 160
Inclusion Criteria
Not provided
Exclusion Criteria
1) Type 1 diabetes mellitus 2) Pregnancy 3) Severe renal disease (CCr<30 mL/min, sCr >= 2.0 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1) AGT (urine and serum): 0, 6 and 12 months 2) Albumin (urine): 0, 6 and 12 months
- Secondary Outcome Measures
Name Time Method 1) BP: 0, 2, 4, 6, 8, 10 and 12 months 2) BW, BMI, waist circumference:0, 6 and 12 months 3) FBS, insulin, HbA1c: 0, 6 and 12 months 4) PRA, Aldosterone: 0 and 12 months 5) T-chol, LDL-chol, HDL-chol, TG: 0 and 12 months 6) Cr, BUN, UA: 0, 6 and 12 months 7) Cardiovascular events: 0-12 months 8) Insulin sensitivity: 0, 6 and 12 months 9) hsCRP: 0, 6 and 12 months