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

Phase 4

• Conditions: Efficacy of Olmesartan on Cerebral Glucose Metabolism in Essential Hypertension
• Interventions: Drug: Amlodipine; Drug: Olmesartan

• Registration Number: NCT02996916
• Lead Sponsor: Kurume University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12
• Status Verified: 2016-12
• Study First Submitted: 2016-12-13
• Study First Submitted QC: 2016-12-14
• Last Update Submitted: 2016-12-16
• Study First Posted: 2016-12-19
• Last Update Posted: 2016-12-20
• Primary Completion: 2018-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Amlodipine	Amlodipine	Amlodipine 2.5-10mg daily
Olmesartan	Olmesartan	Olmesartan 10-40mg daily

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Kurume University Hospital; 🇯🇵 Kurume, Japan