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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02996916

Enrollment

100

Registered

2016-12-19

Start date

2015-12-31

Completion date

2020-12-31

Last updated

2016-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Efficacy of Olmesartan on Cerebral Glucose Metabolism in Essential Hypertension

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.

Interventions

DRUGOlmesartan

10-40mg daily

DRUGAmlodipine

2.5-10mg daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

Japan

Contacts

Primary ContactNobuhiro Tahara, MD, PhD

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026