Efficacy of Olmesartan on Cerebral Glucose Metabolism, Vascular Inflammation and Adipose Tissue

Kurume University100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Efficacy of Olmesartan on Cerebral Glucose Metabolism in Essential Hypertension

Interventions

OlmesartanDRUG

10-40mg daily

AmlodipineDRUG

2.5-10mg daily

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (1)

Kurume University Hospital

Kurume, Japan

RECRUITING

Outcomes

Primary Outcomes

Effects of treatment on the nominal change in cerebral glucose metabolism from baseline after 6 months of treatment as measured by FDG-PET/CT

Time frame: 6 months of treatment

Secondary Outcomes

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

Time frame: 6 months of treatment

Change from baseline in abdominal and muscle fat volume as measured by CT

Time frame: 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)

Time frame: 6 months of treatment

Central Contacts

Nobuhiro Tahara, MD, PhD

CONTACT

+81-942-31-7580 ntahara@med.kurume-u.ac.jp

Data from ClinicalTrials.gov

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