Effects of SGLT-2 Inhibition on Sympathetic Nervous System Activity in Humans
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Reduction in renal sympathetic nerve activity
研究概览
简要总结
This study is designed to investigate whether the sodium-glucose co-transporter-2 (SGLT-2) inhibitor Empagliflozin reduces sympathetic nervous system (SNS) activity in humans.
详细描述
This is a randomised, double-blind, placebo controlled, cross-over study. Participants will be randomly assigned to receive either Empagliflozin 10mg/daily or Placebo and will later receive the alternate treatment.
Comprehensive testing will occur after each 4 week treatment phase and will include assessment of muscle sympathetic nerve activity, cardiac and renal noradrenaline spillover to assess organ specific SNS activity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 25 -65 years
- •(Body Mass Index) BMI≥30kg/m2
- •Currently weight stable (+/- 3% in previous 6-12 months and not on any specific exercise or dietary program)
- •Metabolic syndrome (defined as having: obesity (BMI ≥30kg/m2 ) plus any two of the following four factors: Elevated triglycerides (Triglyceride≥ 1.7mmol/L), Reduced HDL (High - density lipoprotein) cholesterol (<1.0mmol/L in males, <1.3mmol/L in females), Elevated clinic systolic (Blood Pressure) BP ≥130 or diastolic BP ≥85mmHg, Fasting glucose ≥5.6mmol/L or type 2 diabetes.
- •office BP for screening purposes ≤160/90mmHg
- •drug naïve for at least 6 weeks prior to baseline assessment
排除标准
- •Grade 2-3 hypertension (systolic office BP >160, diastolic office BP >100 mmHg)
- •Secondary causes of hypertension
- •CKD (Chronic kidney disease) stage 4-5 {(estimated glomerular filtration) eGFR<30ml/min}
- •Heart failure NYHA (New York Heart Association) class II-IV
- •Recent CV (cardiovascular) event (acute myocardial infarction, acute coronary syndrome, stroke or transient ischaemic attack within the previous six months)
- •unstable psychiatric condition
- •medication such as corticosteroids, several antidepressants and antipsychotics
- •Female participants of childbearing potential must have a negative pregnancy test prior to treatment
研究组 & 干预措施
Phase 1
Empagliflozin 10mg daily or placebo
干预措施: Empagliflozin Oral Tablet [Jardiance] (Drug)
Phase 1
Empagliflozin 10mg daily or placebo
干预措施: Placebo Oral Tablet (Drug)
Phase2
Empagliflozin 10mg daily or placebo
干预措施: Empagliflozin Oral Tablet [Jardiance] (Drug)
Phase2
Empagliflozin 10mg daily or placebo
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
Reduction in renal sympathetic nerve activity
时间窗: 18 weeks
Renal sympathetic nerve activity assessed by renal noradrenaline spillover
Reduction in muscle sympathetic nerve activity
时间窗: 18 weeks
Muscle sympathetic nerve activity assessed by microneurography
Reduction in cardiac sympathetic nerve activity
时间窗: 18 weeks
Cardiac sympathetic nerve activity assessed by cardiac noradrenaline spillover
次要结局
- Reduction in ambulatory BP (blood pressure)(18 weeks)
- Change in urinary sodium excretion(18 weeks)
- Reduction in central Blood Pressure(18 weeks)
- Change in glycemic control(18 weeks)
研究者
Dr Markus Schlaich
Principal Investigator
Royal Perth Hospital