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

Augusta University

Status: Active, not recruiting

Conditions: Cardiovascular Disease

Treatments: Other: Placebo; Dietary Supplement: Antioxidant cocktail; Drug: NMD; 0.4mg sub-lingual nitroglycerin spray; Other: Biopsy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02115724

NO-Stress Pro00001887

5P01HL069999 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 74 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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74 participants in 2 patient groups

Antioxidant Cocktail

Experimental group

Description:

Following an overnight fast, blood samples, flow-mediated dilation, and nitroglycerin mediated dilation (NMD; 0.4mg sub-lingual nitroglycerin spray) will be performed at baseline and 2 hours following either a single dose oral antioxidant cocktail (1000 mg Vitamin C, 600 IU vitamin E, 600 mg Alpha Lipoic Acid) or placebo on two days separated by at least 72 hours.

Treatment:

Drug: NMD; 0.4mg sub-lingual nitroglycerin spray

Dietary Supplement: Antioxidant cocktail

Other: Placebo

Biopsy

Other group

Description:

Following an overnight fast, a subcutaneous gluteal/hip fat biopsy sample will be obtained from each subject under local anesthesia, with adipose tissue (\~2x1.5x1.5cm) to be harvested and placed immediately in physiological saline solution (PSS): Small arteries, 100 to 150 um in diameter, will be dissected from the fat under a dissecting microscope, transferred to an arteriographic bath chamber, and cannulated for pressurized myography.

Treatment:

Other: Biopsy