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

Sponsor
Kurume University (Other)
Overall Status
Unknown status
CT.gov ID
NCT02996916
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
60
Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Efficacy of Olmesartan on Cerebral Glucose Metabolism, Vascular Inflammation and Adipose Tissue
Study Start Date :
Dec 1, 2015
Anticipated Primary Completion Date :
Dec 1, 2018
Anticipated Study Completion Date :
Dec 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Olmesartan

Olmesartan 10-40mg daily

Drug: Olmesartan
10-40mg daily
Active Comparator: Amlodipine

Amlodipine 2.5-10mg daily

Drug: Amlodipine
2.5-10mg daily

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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]

  2. Change from baseline in abdominal and muscle fat volume as measured by CT [6 months of treatment]

  3. 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Kurume University Hospital Kurume Japan 830-0011

Sponsors and Collaborators

  • Kurume University

Investigators

  • Study Chair: Nobuhiro Tahara, MD, PhD, Department of Medicine, Division of Cardiovascular Medicine, Kurume University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nobuhiro Tahara, Associate Professor, Kurume University
ClinicalTrials.gov Identifier:
NCT02996916
Other Study ID Numbers:
  • Olme-brain
First Posted:
Dec 19, 2016
Last Update Posted:
Dec 20, 2016
Last Verified:
Dec 1, 2016
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Additional relevant MeSH terms:
Essential Hypertension
Inflammation
Amlodipine
Olmesartan

Study Results

No Results Posted as of Dec 20, 2016