ROS Signaling in Endothelial Function

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Joseph A. Vita, Boston University
ClinicalTrials.gov Identifier:
NCT01037465
First received: December 19, 2009
Last updated: July 23, 2013
Last verified: July 2013
  Purpose

The vascular endothelium (inner lining of cells in blood vessels) normally prevents vasospasm and thrombosis by producing nitric oxide and other regulatory substances. In patients with atherosclerosis, endothelial function is impaired. Excess production of reactive oxygen species (free radicals) contribute to endothelial dysfunction in atherosclerosis, and some prior studies have shown a beneficial effect of antioxidant treatment on endothelial function in patients with coronary artery disease. On the other hand, reactive oxygen species may be required for normal endothelial function and antioxidant supplements failed to show a benefit in large clinical trials. The effect of antioxidant treatment on endothelial function in healthy subjects is unknown. The present study will test the hypothesis that scavenging reactive species might reduce endothelium-dependent vasodilation in healthy subjects.

The study is a randomized, double-blind, placebo-controlled crossover study. Participants will receive 2.4 grams of oral NAC or similar-appearing placebo during the first visit, and then will cross over to the alternative treatment (NAC or placebo) for the second and final visit. We will examine endothelial function before and after treatment on each visit.


Condition Intervention
Cardiovascular Disease
Drug: N-acetylcysteine
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: ROS Signaling in Endothelial Function

Resource links provided by NLM:


Further study details as provided by Boston University:

Primary Outcome Measures:
  • Brachial artery flow-mediated dilation [ Time Frame: 4 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Blood markers of antioxidant capacity [ Time Frame: 4 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 43
Study Start Date: September 2008
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: N-acetylcysteine
N-acetylcysteine
Drug: N-acetylcysteine
N-acetylcysteine
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Placebo

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Sex: Male and Female subjects.
  2. Age range: 21-65 years old.
  3. Disease status: No acute, chronic, or debilitating medical condition or use of prescribed medications.
  4. Willingness and ability to provide written informed consent and the ability to understand, to participate and to comply with the study requirements.

Exclusion Criteria:

  1. Women with a positive urine beta HCG pregnancy test and lactating women.
  2. Blood pressure greater than 140/90 mmHg; serum LDL cholesterol greater than 160 mg/dl; fasting blood sugar greater than 110 mg/dl.
  3. History of any cigarette smoking within one year of the study.
  4. Clinical history of any acute, chronic, or debilitating medical condition, including liver disease and peptic ulcer disease.
  5. Treatment with an investigational new drug within the last 30 days.
  6. History of a psychological illness or condition such as to interfere with the subject's ability to understand the requirements of the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01037465

Locations
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston University
Investigators
Principal Investigator: Joseph A Vita, MD Boston University
  More Information

No publications provided

Responsible Party: Joseph A. Vita, Professor of Medicine, Boston University
ClinicalTrials.gov Identifier: NCT01037465     History of Changes
Other Study ID Numbers: H-26547
Study First Received: December 19, 2009
Last Updated: July 23, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Boston University:
endothelium
cell signaling
N-acetylcysteine
reactive oxygen species

Additional relevant MeSH terms:
Cardiovascular Diseases
Acetylcysteine
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes

ClinicalTrials.gov processed this record on April 16, 2014