SGLT2 Inhibition as a Therapeutic Strategy to Reverse Arterial Stiffening in Aging
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Carotid Femoral Pulse Wave Velocity (cfPWV)
研究概览
简要总结
Randomized placebo-controlled clinical trial in a cohort of males (n=40) and females (n=40), 60-80 years of age, with the hypothesis that SGLT2 inhibition with empagliflozin (10mg/day for 12 weeks) reduces aging-related arterial stiffening.
详细描述
The investigators will employ a double-blinded randomized placebo control trial to determine the effects of 12 weeks of sodium glucose co-transporter 2 (SGLT2) inhibition with empagliflozin (10 mg daily), or matching placebo. Empagliflozin has been shown to decrease cardiovascular events and arterial stiffness in different populations. Placebo will be included for comparison purposes as empagliflozin is not a standard therapy for aging-associated arterial stiffness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
double-blinded
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Able to provide consent
- •60 to 80 years of age at randomization (women must be postmenopausal defined as more than 1 year without menses)
- •Stable anti-hypertensive medication regimen (if in use) for at least 90 days
- •Evidence of arterial stiffening (defined as carotid-femoral PWV >/= 8 m/s) at the time of screening visit.
排除标准
- •BMI>/= 45kg/m2
- •Known history of cardiovascular disease: heart failure, ischemic heart disease, peripheral artery disease or stroke
- •Estimated glomerular filtration rate GFR < 29 mL/min
- •Active cancer (excluding basal cell carcinoma or stage 1 squamous cell carcinoma of the skin)
- •Excessive alcohol consumption (>14 drinks/week for men, >7 drinks/week for women)
- •Use of hormone replacement therapy
- •Body weight change ≥10% within the last 6 months
- •Uncontrolled hypertension during screening visit (>180/110 mmHg)
- •Symptomatic hypotension and/or a SBP <100 mmHg
- •History of ketoacidosis
- •High fall risk per assessment of study physician and/or safety officer at the time of screening (results must be abnormal for both fall risk assessments and orthostatic blood pressure measurements)
- •Anticipated need of prolonged fasting
- •History of recurrent UTIs or mycotic genital infections
- •Following a low-carbohydrate diet (<20 grams/day)
- •Participation in regular exercise > 3 days/week per week at a moderate or vigorous intensity
- •Known sensitivity to nitrate medications
研究组 & 干预措施
Placebo
10mg Placebo daily for 12 weeks
干预措施: Placebo (Drug)
Empagliflozin
10mg Empagliflozin daily for 12 weeks
干预措施: Empagliflozin 10 MG (Drug)
结局指标
主要结局
Carotid Femoral Pulse Wave Velocity (cfPWV)
时间窗: Baseline (day 0), Week 4, Week 8, Final (week 12)
cfPWV is the gold standard non-invasive index of arterial stiffness. Transit time between carotid and femoral pressure waves is calculated using the foot-to-foot method. cfPWV is calculated as distance traveled by the pulse wave (i.e., femoral location-sternal notch minus sternal notch-carotid location) divided by pulse transit time. All the measurements will be done by the same blinded technician. The goal is to assess changes from baseline when compared to weeks 4,8, and 12 time points. Report
次要结局
未报告次要终点
研究者
Camila Manrique, MD
Professor of Medicine
University of Missouri-Columbia