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ROS Signaling in Endothelial Function

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01037465
First Posted: December 23, 2009
Last Update Posted: March 10, 2017
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. Read our disclaimer for details.
Information provided by (Responsible Party):
Naomi M Hamburg, Boston University
  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 (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: ROS Signaling in Endothelial Function

Resource links provided by NLM:


Further study details as provided by Naomi M Hamburg, Boston University:

Primary Outcome Measures:
  • Brachial artery flow-mediated dilation [ Time Frame: 4 hours ]

Secondary Outcome Measures:
  • Blood markers of antioxidant capacity [ Time Frame: 4 hours ]

Enrollment: 72
Study Start Date: September 2008
Study Completion Date: March 26, 2016
Primary Completion Date: December 2015 (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

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.


Ages Eligible for Study:   21 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): NCT01037465


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

Responsible Party: Naomi M Hamburg, Principal Investigator, Boston University
ClinicalTrials.gov Identifier: NCT01037465     History of Changes
Other Study ID Numbers: H-26547
First Submitted: December 19, 2009
First Posted: December 23, 2009
Last Update Posted: March 10, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Naomi M Hamburg, Boston University:
endothelium
cell signaling
N-acetylcysteine
reactive oxygen species

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