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Active, Not Recruiting

NCT Number: NCT02115724

Nitric Oxide Bioavailability and Early Life Stress (NO-Stress)

Cardiovascular disease is the leading cause of death in the United States. Other studies have shown that stress, early in life, could be a risk factor for cardiovascular disease, later in life. This study will look at the effect of early life stressors on your cardiovascular health.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Cardiovascular Disease Behavior Behavioral Symptoms Cardiovascular Diseases Stress, Psychological

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Georgia Prevention Institute , Georgia Regents University

Augusta, Georgia, 30912, United States

About this study

This study will have two parts involved to investigate the role that childhood SES status has on cardiovascular health.

Part one: Subjects will give a blood sample which will be processed and analyzed. Flow mediated dilation (FMD) and Pulse wave velocity (PWV/PWA) will be performed at baseline and 2 hours following either a single dose oral antioxidant cocktail (1000 mg of Vitamin C, 600 IU of Vitamin E, and 600 mg of alpha-lipoic acid) or placebo on two days separated by at least 72 hours. Nitroglycerin mediated dilation (NMD, 0.4mg sub-lingual nitroglycerin spray), will be assessed at baseline.

Part two: Subjects, if interested will undergo a subcutaneous gluteal/hip fat biopsy. Micro vessels will be isolated from the adipose tissue and analyzed by pressurized myography for endothelial function and nitric oxide bioavailability.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • documented childhood SES
  • men and premenopausal women ages 18-40
  • lean/overweight/or obese with BMI< or equal to 39kg/m2

Exclusion criteria

  • cardiovascular, renal, pulmonary, hepatic, cerebral, or metabolic,disease
  • use medications that affect vascular tone
  • post menopausal women
  • have class 3 obesity or BMI over 40

Treatment and study plan

Antioxidant cocktail

Dietary Supplement

Flow-Mediated Dilation will be determined at baseline and 2 hours following acute antioxidant treatment

Other names: Vitamin C, Vitamin E, Alpha Lipoic Acid

Biopsy

Other

Under sterile conditions, a small incision (¼ - ½ inch) by the study doctor will be made and the piece of fat will be taken out. Fat tissue was chosen for this study because it is a big source of small blood vessels which we are studying

Placebo

Other

Flow-Mediated Dilation will be determined at baseline and 2 hours following acute antioxidant treatment

NMD; 0.4mg sub-lingual nitroglycerin spray

Drug

Nitroglycerin mediated dilation will be measured immediately following an administered 0.4mg dose of nitroglycerin spray, sub-lingual.

Other names: Generic name: Nitrolingual, Manufacturer: Arbor Pharmaceuticals

Primary outcomes

  1. Acute Change in Flow mediated dilation

    Time frame: Change from baseline (2 hours)

    Flow-Mediated Dilation will be determined at baseline and 2 hours following acute antioxidant treatment

Secondary outcomes

  1. Acute Change in Biomarkers of oxidative stress

    Time frame: Change from baseline (2 hours)

    Nitrite/nitrate, antioxidant capacity, and 8-isoprostane at baseline and 2 hours following acute antioxidant treatment

  2. Acute Change in Arterial Stiffness

    Time frame: Change from baseline (2 hours)

    Pulse wave velocity will be determined at baseline and 2 hours following acute antioxidant treatment

  3. Acute change in Flow mediated dilation

    Time frame: Immediate

    Nitroglycerin mediated dilation will be measured immediately following an administered 0.4mg dose of nitroglycerin spray, sub-lingual.

Sponsors and collaborators

Lead sponsor

Augusta University

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Effect of Low Childhood Socioeconomic Status (SES) on Adult Endothelial Function and Nitric Oxide Bioavailability in Vivo and ex Vivo

Acronym: NO-Stress

Important dates

Study start
2014
Primary completion
2026
Study completion
2027
First posted
Apr 16, 2014
Registry last updated
Jan 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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