Diabetes mellitus Hypertension
Conditions
Interventions
ARB:olmesartan
Ca-blocker:azelnidipine
Sponsors
Saitama Medical Center, Saitama Medical University Department of endocrinology and dibaetes
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Subjects are under the treatment of diabetes mellitus 2) Systolic blood pressure more than or equal to 130mmHg, or diastolic blood pressure more than or equal to 80mmHg, measured at the hospital 3) Urine albumin / Cr more than or equal to 300 mg/g cr 4) Serum Cr less than or equal to 2.0 mg/dl Subjects with all above criteria will be included.
Exclusion criteria
Exclusion criteria: Subjects who have one or more of the below cases will be excluded. 1) Hypertensive emergency, or under non-oral anti-hypertensive medication 2) Nephritic syndrome (urine protein more than 3.5 g/day, or serum albumin is less than or equal to 3.0 g/dL 3) Subjects who take steroid or immunosuppressor, or ARB other than olmesartan, Ca-blocker other than azelnidipin, anti-fungal agents, HIV protease inhibitor, will be excluded. Subjects who take NSAIDs for more than or equal to 2 weeks will be excluded. 4) Previous history of sever adverse events with Ca-blocker, or ARB or ACE. 5) Subjects experienced brain stroke during six months before taking experimental medication will be excluded. 6) Sever congestive heart failure (NYHA class III or more), sever arrhythmia. Subjects experienced myocardial infarction, or PCT intervention during six months before taking experimental medical will be excluded. 7) Type 1 diabetes mellitus. HbA1C (JDS) more than or equal to 9.0%. Diabetic ketoacidosis 8) Liver dysfunction with increased AST or ALT which are more than 5 times than the upper limit of the standard value. 9) Subjects with malignant tumor 10) Pregnant, or expecting to be pregnant 11) Other problems which investigator (physician) felt inappropriate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference of endothelial function measured by FMD (FLOW Mediated Dilation) before and after the addition of ARB or Ca-blocker | — |
Secondary
| Measure | Time frame |
|---|---|
| Difference of blood pressure and urine protein examination before and after the addition of ARB or Ca-blocker | — |
Countries
Japan
Contacts
Public ContactYoshitaka Akiyama
Saitama Medical Center, Saitama Medical University Department of endocrinology and dibaetes
Outcome results
None listed