A Study on the Effects of Chronotherapy of Hypertension with Olmesartan on Blood-pressure Variability, Sympathetic Function, and Renal Function in Patients with Type 2 Diabetes Mellitus and Hypertensio
Phase 4
- Conditions
- Patients with type 2 DM and hypertension.
- Registration Number
- JPRN-UMIN000010419
- Lead Sponsor
- Division of Cardiovascular Medicine, Department of Medicine, Jichi Medical University School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
Not provided
Exclusion Criteria
Patients who meet any of the following criteria will not be included in the study: 1)Patients with secondary or malignant hypertension 2)Patients with severe heart failure (NYHA Class III or higher) 3)Patients with nephrotic syndrome (or serum creatinine [Cr] >= 3.0 mg/dL) 4)Patients with serious liver or biliary diseases 5)Patients with a history of cardiovascular (myocardial infarction) or cerebral events (cerebral infarction) 6)Patients with endocrine disease 7)Patients with any malignancy 8)Patients determined by the investigator to be not suitable for other reasons
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method (i) Changes in home blood pressure from before to after administration in the morning or before bedtime (early-morning, nighttime, and before bedtime blood pressure and heart rate) and the effect of the time of administration of olmesartan on Na excretion (ii) Effect of morning and pre-bedtime administration on blood-pressure variability (ME difference, mean ME, and day-by-day blood pressure variability)
- Secondary Outcome Measures
Name Time Method (i)Changes in outpatient blood pressure and heart rate from before to after administration (ii)Effect on the sympathetic nervous system: Changes in cortisol levels (iii)Effect on renal function: Changes in urinary albumin and RAAS-related enzyme levels (iv)Effect on cardiac function: Changes in BNP, NT-ProBNP, and hs-cTnT levels (v)Effect on glucose metabolism: Changes in HbA1c and adiponectin levels (vi)Effect on the anti-inflammatory process: Changes in hs-CRP level (vii)Evaluation of safety such as adverse events other than the primary endpoints