Sympathetic-vascular Dysfunction in Obesity and Insulin Resistance
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Efficacy of infusion of ascorbic acid
研究概览
简要总结
The main purpose of research is to examine and understanding the development of hypertension in obese adults with insulin resistance. Findings from our studies will identify unique mechanisms that can be targeted to limit increases in vascular dysfunction and reduce the excessively high prevalence of hypertension and risk for cardiovascular disease (CVD).
This study is testing the health of the blood vessels and the activity of the nerves that control the blood vessels in adults with insulin resistance. The extent to which ascorbic acid (Vitamin C) improves the function of the blood vessels will be determined. The primary outcome is blood pressure, which is the result of blood vessel health and activity of the nerves, and the reduction in blood pressure that is observed with ascorbic acid.
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
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Obese: BMI >30 m/kg2
- •Middle-aged: 35-65 years
- •Participants must be willing and able to discontinue taking any vitamin C or E supplements or omega-3 fatty acids beginning 2 weeks prior.
- •Able and willing to provide written informed consent
排除标准
- •Diabetes mellitus: fasting glucose < 1267 mg/dL and/or HbA1c < 6.5%
- •Currently taking a statin or antihypertension medication
- •Hyperlipidemia: Fasting triglycerides < 250 mg/dL
- •Hypertension: <130/80 mmHg
- •History of heart disease (e.g., myocardial infarction, stent)
- •History of vascular disease (e.g., bypass, stroke)
研究组 & 干预措施
Placebo infusion
Saline will be administered over 2 hours
干预措施: Saline (Drug)
Ascorbic acid infusion
Ascorbic acid solution (American Regent Laboratories Inc.) will be obtained from the KU Investigational Pharmacy located in the University of Kansas (KU) Clinical Research Center where studies will take place. A priming bolus of 0.06 g ascorbic acid/kg fat free mass (FFM) dissolved in 100 mL of saline will be infused intravenously at 5 mL/min for 20 minutes, followed immediately by a "drip-infusion" of 0.02 g/kg FFM dissolved in 30 mL of saline administered over 2 hours at 0.5 mL/min.
干预措施: Ascorbic acid solution (American Regent Laboratories Inc.) (Drug)
结局指标
主要结局
Efficacy of infusion of ascorbic acid
时间窗: 120 minutes
The difference in sympathetic-vascular transduction (mmHg) between ascorbic acid and placebo infusion will be taken as a measure of the modulation of SVT by oxidative stress.
次要结局
未报告次要终点
研究者
Seth Holwerda PhD
Principal Investigator
University of Kansas Medical Center