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

Cardiovascular Disease Clinical Trial

— NO-Stress  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02115724
• Other study ID #: NO-Stress Pro00001887
• Secondary ID: 5P01HL069999
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 2014
• Est. completion date: January 2025

Study information

• Verified date: July 2023
• Source: Augusta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 74
• Est. completion date: January 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

Dietary Supplement:
• Antioxidant cocktail
Flow-Mediated Dilation will be determined at baseline and 2 hours following acute antioxidant treatment

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

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

Locations

Country	Name	City	State
United States	Georgia Prevention Institute , Georgia Regents University	Augusta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Augusta University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute Change in Flow mediated dilation	Flow-Mediated Dilation will be determined at baseline and 2 hours following acute antioxidant treatment	Change from baseline (2 hours)
Secondary	Acute Change in Biomarkers of oxidative stress	Nitrite/nitrate, antioxidant capacity, and 8-isoprostane at baseline and 2 hours following acute antioxidant treatment	Change from baseline (2 hours)
Secondary	Acute Change in Arterial Stiffness	Pulse wave velocity will be determined at baseline and 2 hours following acute antioxidant treatment	Change from baseline (2 hours)
Secondary	Acute change in Flow mediated dilation	Nitroglycerin mediated dilation will be measured immediately following an administered 0.4mg dose of nitroglycerin spray, sub-lingual.	Immediate