Fish Oil Supplementation and Vascular Function in Hypertensive Patients With Hypertriglyceridemia

Overview

The objective of this study is to compare the effects of ciprofibrate versus omega-3 fatty acid supplementation on the vascular structure and function in hypertensive patients with hypertriglyceridemia.

Full Title of Study: “Effects of Fish Oil Supplementation on Vascular Structure and Function in Hypertensive Patients With Hypertriglyceridemia”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: December 2012

Detailed Description

Hypertensive patients aged 40-65 years, both genders, presenting serum triglycerides levels higher than 150 mg/dl will be randomized into two groups. The first group will be receiving ciprofibrate 100mg/day and the second group will be receiving fish oil 1800mg/day. All patients will be evaluated with brachial flow-mediated dilation and with EndoPAT to assess endothelial function before and after supplementation. SPHYGMOCOR and pulse wave velocity (PWV) measurements will also be obtained.

Interventions

  • Dietary Supplement: DHA-EPA
    • 1800 mg/day
  • Drug: Ciprofibrate
    • 100 mg/day

Arms, Groups and Cohorts

  • Experimental: Omega-3 fatty acid
  • Active Comparator: Ciprofibrate

Clinical Trial Outcome Measures

Primary Measures

  • Endothelial function
    • Time Frame: 3 months
    • Endothelial function evaluated by brachial flow-mediated dilation and by peripheral arterial tonometry.

Participating in This Clinical Trial

Inclusion Criteria

  • Previous diagnosis of hypertension – Patients with serum triglycerides levels ≥ 150 mg/dl and <500 mg/dl – Patients on stable antihypertensive medication for at least 4 weeks – Patients with food consumption maintained for at least 4 weeks Exclusion Criteria:

  • Smoking – Secondary hypertension – Hormone replacement therapy – Diabetes mellitus – Chronic kidney disease – Known coronary artery disease – Previous stroke – Dyslipidemia severe, with LDL cholesterol> 160 mg/dL or triglycerides ≥ 500 mg/dl – Use of statins or beta blockers

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hospital Universitario Pedro Ernesto
  • Collaborator
    • Rio de Janeiro State Research Supporting Foundation (FAPERJ)
  • Provider of Information About this Clinical Study
    • Principal Investigator: Mario Fritsch Neves, MD, PhD – Hospital Universitario Pedro Ernesto
  • Overall Official(s)
    • Marcela A Casanova, MSc, Principal Investigator, State University of Rio de Janeiro
    • Mario F Neves, MD, PhD, Study Chair, State University of Rio de Janeiro
    • Wille Oigman, MD, PhD, Study Chair, State University of Rio de Janeiro
    • Fernanda J Medeiros, PhD, Study Chair, Federal University of the State of Rio de Janeiro
  • Overall Contact(s)
    • Marcela A. Casanova, MSc, 55-21-2868-8484, cela.abreu@gmail.com

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