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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02996916
Recruitment Status : Recruiting
First Posted : December 19, 2016
Last Update Posted : December 20, 2016
Information provided by (Responsible Party):
Nobuhiro Tahara, 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.

Condition or disease Intervention/treatment Phase
Efficacy of Olmesartan on Cerebral Glucose Metabolism in Essential Hypertension Drug: Olmesartan Drug: Amlodipine Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : December 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02996916

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Contact: Nobuhiro Tahara, MD, PhD +81-942-31-7580

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Kurume University Hospital Recruiting
Kurume, Japan, 830-0011
Contact: Nobuhiro Tahara, MD, PhD    +81-942-31-7580   
Contact: Akihiro Honda, MD, PhD    +81-942-31-7580   
Sponsors and Collaborators
Kurume University
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Study Chair: Nobuhiro Tahara, MD, PhD Department of Medicine, Division of Cardiovascular Medicine, Kurume University School of Medicine
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Responsible Party: Nobuhiro Tahara, Associate Professor, Kurume University Identifier: NCT02996916    
Other Study ID Numbers: Olme-brain
First Posted: December 19, 2016    Key Record Dates
Last Update Posted: December 20, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Essential Hypertension
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists