Efficacy of Olmesartan on Cerebral Glucose Metabolism, Vascular Inflammation and Adipose Tissue
试验速览
- 阶段
- 4 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Effects of treatment on the nominal change in cerebral glucose metabolism from baseline after 6 months of treatment as measured by FDG-PET/CT
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Olmesartan
Olmesartan 10-40mg daily
干预措施: Olmesartan (Drug)
Amlodipine
Amlodipine 2.5-10mg daily
干预措施: Amlodipine (Drug)
结局指标
主要结局
Effects of treatment on the nominal change in cerebral glucose metabolism from baseline after 6 months of treatment as measured by FDG-PET/CT
时间窗: 6 months of treatment
次要结局
- 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)
- Change from baseline in abdominal and muscle fat volume as measured by CT(6 months of treatment)
- 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)
研究者
Nobuhiro Tahara
Associate Professor
Kurume University