Forebrain Electroneutral Transporters in Salt-sensitive Hypertension: an MRI Study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Bold fMRI
研究概览
简要总结
The overall objective of this project is to identify the key salt-sensing regions of the brain and determine the underlying mechanism of sodium sensing. The investigators will assess how the brain responds to an acute increase of salt in the blood using MRI. This will be done during a 30-minute infusion of a saline solution containing 3% salt. One trial will be conducted with a salt sensing channel blocker and one trial without the salt sensing channel blocker. This will help to assess the role of a specific salt sensing channel in the brain. Salt sensitivity of BP will be assessed using 7-day dietary feeding where participants will be given food to consume for 7-days. Comparisons will be made between salt resistant (no change in blood pressure going from low to high salt diets) and salt sensitive adults (a change in blood pressure going from low to high salt diets). The investigators think the changes in MRI will be greater in salt sensitive compared to salt resistant subjects.
详细描述
The ability of the brain to sense changing sodium levels in the blood is critical in mediating the neurohumoral responses to hypernatremia, however, the mechanisms underlying sodium sensing in humans is poorly understood. The purpose of this study is to identify key sodium-sensing regions of the human brain in middle-aged men and women with high blood pressure and determine if the Na-K-2Cl co-transporter (NKCC2) mediates the neurohumoral response to acute hypernatremia. The investigators plan on comparing these central sodium responses to acute hypernatremia between salt-sensitive and salt-resistant adults. In this randomized double-blinded crossover study subjects will have a 3% NaCl (hypertonic saline) infusion with or without NKCC2 antagonism (furosemide). Completion of this project will increase the understanding of blood pressure regulation, which has major public health implications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: > 40 years or < 60 years
- •Blood pressure: > 100/60 mmHg or < 140/90 mmHg
- •BMI: > 18.5 kg/m2 or < 35 kg/m2
- •Serum potassium: > 3.5 mmol/L or < 5.5 mmol/L
- •No history of cardiovascular, renal, metabolic, or neurological disease
排除标准
- •Age: < 40 years or > 60 years
- •Blood pressure: < 100/60 mmHg or > 140/90 mmHg
- •BMI: < 18.5 kg/m2 or > 30 kg/m2
- •Serum potassium: < 3.5 mmol/L or > 5.5 mmol/L
- •Abnormal ECG
- •History of - cardiovascular, cancer, metabolic, respiratory, renal disease
- •Hormone replacement therapy
- •Current tobacco or nicotine use
- •Pregnant or nursing mothers
- •Major brain injury (concussions do not count)
- •Clinically diagnosed psychiatric or neurological disorder
- •Clinically diagnosed anxiety or depression
- •Psychiatric, neurological, anxiety or depression medications
- •Hypertension medications
- •Sulfonamide drug allergy
- •Contra-indications to MRI (implants, metal, etc)
- •Claustrophobia
研究组 & 干预措施
Salt Resistant Adults
Adults who experience minimal BP change during dietary sodium challenge
干预措施: Furosemide (Diuretic) (Drug)
Salt Resistant Adults
Adults who experience minimal BP change during dietary sodium challenge
干预措施: Hypertonic Saline Infusion (Other)
Salt Sensitive
Adults who experience increased BP (mean arterial pressures >5mmHg) during dietary sodium challenge
干预措施: Furosemide (Diuretic) (Drug)
Salt Sensitive
Adults who experience increased BP (mean arterial pressures >5mmHg) during dietary sodium challenge
干预措施: Hypertonic Saline Infusion (Other)
结局指标
主要结局
Bold fMRI
时间窗: 1 hour
Intensity of sodium sensing regions of the brain
次要结局
- Blood Pressure(1 hour)