Efficacy of Olmesartan on Cerebral Glucose Metabolism in Essential Hypertension Clinical Trial
Official title:
Efficacy of Olmesartan on Cerebral Glucose Metabolism, Vascular Inflammation and Adipose Tissue
Hypertension is a leading risk factor for morbidity and mortality worldwide. The brain is a major target of the damaging effects of hypertension. Hypertension has been recognized as the leading cause of dementia as well as the most important risk factor for stroke and vascular cognitive impairment. Although glucose is the principal cerebral energy source, impact of hypertensive treatment on cerebral glucose metabolism is poorly understood.
| Status | Recruiting |
| Enrollment | 100 |
| Est. completion date | December 2020 |
| Est. primary completion date | December 2018 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 20 Years and older |
| Eligibility |
Inclusion Criteria: - Written informed consent obtained - Male and female subjects aged 20 years or older at informed consent - Essential hypertension who had never received angiotensin II receptor antagonists and calcium channel blockers Exclusion Criteria: - Secondary hypertension or malignant hypertension - Diabetes mellitus - History or evidence of a stroke - Hepatic or hematologic abnormality - Mild Cognitive Impairment or Dementia - Serum potassium level = 5.5 mEq/L - Serum creatinine level = 3.0 mg/dL - Acute or chronic disease - Allergy to any drugs - Pregnancy |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Japan | Kurume University Hospital | Kurume |
| Lead Sponsor | Collaborator |
|---|---|
| Kurume University |
Japan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Effects of treatment on the nominal change in cerebral glucose metabolism from baseline after 6 months of treatment as measured by FDG-PET/CT | 6 months of treatment | Yes | |
| Secondary | Change from baseline in vascular inflammation measured by blood-normalized standardized uptake value, known as a target-to-background ratio (TBR) by FDG-PET/CT | 6 months of treatment | Yes | |
| Secondary | Change from baseline in abdominal and muscle fat volume as measured by CT | 6 months of treatment | Yes | |
| Secondary | Change from baseline in circulating inflammatory markers including hsCRP (mg/L), adiponectin (µg/mL), ADMA (nmoL/mL), DPP-4 (ng/mL), advanced glycation end products (AGEs, µg/mL) and angiotensin-(1-7) (ng/mL) | 6 months of treatment | Yes |