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

December 19, 2009
July 23, 2013
September 2008
December 2014   (final data collection date for primary outcome measure)
Brachial artery flow-mediated dilation [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01037465 on ClinicalTrials.gov Archive Site
Blood markers of antioxidant capacity [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
ROS Signaling in Endothelial Function
ROS Signaling in Endothelial Function

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Cardiovascular Disease
  • Drug: N-acetylcysteine
    N-acetylcysteine
  • Drug: Placebo
    Placebo
  • Active Comparator: N-acetylcysteine
    N-acetylcysteine
    Intervention: Drug: N-acetylcysteine
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
43
December 2014
December 2014   (final data collection date for primary outcome measure)

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.
Both
21 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01037465
H-26547
No
Joseph A. Vita, Boston University
Boston University
Not Provided
Principal Investigator: Joseph A Vita, MD Boston University
Boston University
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP