An open label multi facilities cooperation randomized control trial to verify urinary angiotensinogen excretion reducing effect of olmesartan therapy in diabetic nephropathy

INTERVENTION: This Study is a prospective randomized control trial. The entry period of this study is one year. Subjects are hypertensive diabetic nephropathy, who has not been taken RAS inhibitors. The patients are randomly assigned to two groups, a Olmesartan group (20mg/day or 40 mg/day) and Nifedipine CR group (20 mg/day or 40 mg/day). Both drugs can be properly increased to 40 mg/day, when the anti‐hypertensive effect is insufficient. The subjects were given Olmesartan or Nifedipine CR, and the following parameters were measured before administration and 16 weeks later: blood pressure, body weight, hemoglobin A1c, serum creatinine, urinary angiotensinogen, oxidative stress markers such as 8‐epi‐prostaglandinF2alpha and 8‐hydroxydeoxyguanosine, inflammatory makers such as monocyte chemoattractant protein‐1, interleukin‐6, and albumin‐to‐creatinine ratio (ACR). CONDITION: Hypertensive type2 diabetic nephropathy patients with chronic kidney disease (CKD) PRIMARY OUTCOME: Changes of urinary angiotensinogen excretion, monocyte chemoattractant protein (MCP)‐1, interleukin (IL)‐6, 8‐epi prostaglandin F2alpha 8‐hydroxydeoxyguanosine, albumin excretion (albumin to creatinine ratio: ACR) and blood pressure. INCLUSION CRITERIA: The subjects enrolled in the present study are hypertensive type 2 diabetic outpatients with nephropathy, who visit our hospitals and fulfilled the following criteria: 1) mild or moderate hypertension (blood pressure 130‐200/90‐110 mmHg) 2) mild or moderate hyperglycemia (HbA1c < 8%) 3) an urinary albumin excretion higher than 30 mg/g creatinine.