Lysine-specific Demethylase 1 and Salt-sensitivity in Humans
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- Aldosterone response to angiotensin II
研究概览
简要总结
The purpose of this study is to investigate the role dietary salt plays in epigenetic regulation of blood pressure, focusing on the salt-sensitive regulatory enzyme Lysine-specific demethylase 1.
详细描述
The purpose of this study is to investigate the role dietary salt plays in epigenetic regulation of blood pressure in African American and Caucasians, focusing on the salt-sensitive regulatory enzyme Lysine-specific demethylase 1. This might help us understand why some people develop high blood pressure.
Healthy volunteers will be screened for eligibility and invited to participate in a 2 weeks study. Week 1 will be consumption of a low salt diet. Week 2 will be a high salt diet.
At the end of each week, participants will be admitted to a Clinical Research Center overnight and for one day.
On the CRC, participants will remain fasting and supine overnight and then next morning undergo hormonal and vascular testing. This will consist of blood drawing, echocardiogram, vascular tonometry, and assessment of renal blood flow before and after a low-dose Angiotensin II infusion.
The study outcome will compare how variants in the LSD1 gene affect hormonal and vascular responses according to race. This information will help us determine why some races and genetic profiles are more susceptible to detrimental effects of salt in the diet while others are protected against these effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 25-45 years
- •Caucasian or African American
- •No gender preference (anticipate 50% female)
- •Normotensive (screening blood pressure <140/90 mmHg)
- •No history of hypertension, diabetes, stroke, coronary artery disease, kidney disease, cancer, thyroid disease, preeclampsia, or hospitalizations in 6 months
- •Normal screening laboratory values (CMP, TSH, A1c)
- •Normal ECG
- •BMI <25 kg/m2
排除标准
- •Pregnancy
- •Breast feeding
- •Any medication or herbal preparation
- •>6oz alcohol/week
- •Tobacco use
- •Illicit drug use
- •Chronic NSAID use
- •Recent steroid use (injected, inhaled, oral)
- •Decongestant use in the past 2 weeks
- •Known sensitivity to infused Angiotensin II or para-amino hippurate
结局指标
主要结局
Aldosterone response to angiotensin II
时间窗: After 1 week dietary salt manipulation
Change in aldosterone, baseline to after angiotensin II by genotype/race
次要结局
- Vascular stiffness response to angiotensin II(After 1 week dietary salt manipulation)
- Renal blood flow response to dietary salt(After 1 week dietary salt manipulation on both diets)
研究者
Jonathan S. Williams, MD, MMSc
Associate Physician, Brigham and Women's Hospital
Brigham and Women's Hospital