Effect of Low Childhood Socioeconomic Status (SES) on Adult Endothelial Function and Nitric Oxide Bioavailability in Vivo and ex Vivo
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Acute Change in Flow mediated dilation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •documented childhood SES
- •men and premenopausal women ages 18-40
- •lean/overweight/or obese with BMI< or equal to 39kg/m2
排除标准
- •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
研究组 & 干预措施
Antioxidant Cocktail
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.
干预措施: Antioxidant cocktail (Dietary Supplement)
Antioxidant Cocktail
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.
干预措施: Placebo (Other)
Antioxidant Cocktail
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.
干预措施: NMD; 0.4mg sub-lingual nitroglycerin spray (Drug)
Biopsy
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.
干预措施: Biopsy (Other)
结局指标
主要结局
Acute Change in Flow mediated dilation
时间窗: Change from baseline (2 hours)
Flow-Mediated Dilation will be determined at baseline and 2 hours following acute antioxidant treatment
次要结局
- Acute Change in Biomarkers of oxidative stress(Change from baseline (2 hours))
- Acute Change in Arterial Stiffness(Change from baseline (2 hours))
- Acute change in Flow mediated dilation(Immediate)
研究者
Ryan Harris
Assistant Professor
Augusta University