Arterial Destiffening Effects of SGLT2 Inhibition in Veterans With Obesity
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Carotid-femoral Pulse Wave Velocity (cfPWV)
研究概览
简要总结
The study will assign participants to take either the medication, empagliflozin or a placebo for 12 weeks. The goal of the study is to determine the effects of empagliflozin on arterial health in Veterans with obesity.
详细描述
The investigators will employ a double-blinded randomized placebo-controlled trial to determine the effects of 12 weeks of SGLT2 inhibition with empagliflozin (10mg daily), or matching placebo, on arterial stiffness in Veterans with obesity. Fifty Veterans with obesity (BMI 30-45kg/m2), 30-60 years of age, will be recruited from the Harry S. Truman Memorial VA Hospital in Columbia, Missouri.
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
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index (BMI) 30-45 kg/m2
- •30-60 years of age at randomization
- •Evidence of arterial stiffening (defined as Carotid femoral PWV>age-predicted) at screening visit (PMID: 20530030)
排除标准
- •Unable to provide consent
- •Diabetes mellitus
- •Uncontrolled hypertension (>180/90mmHg) or systolic <100mmHg at screening visit
- •Known history of cardiovascular disease: heart failure, ischemic heart disease, peripheral artery disease or stroke
- •Diagnosis of chronic kidney disease
- •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 GLP-1 analogs or SGLT2 inhibitors
- •Use of hormone replacement therapy
- •Use of pharmacological therapy for weight loss
- •Body weight changes >10% within the past 6 months
- •History of hypersensitivity to nitrates
- •History of ketoacidosis
- •History of recurrent UTIs or mycotic genital infections
- •Use of anticoagulants
- •Change in anti-hypertensive medication regimen (if in use) during the last 90 days
- •Pregnancy
研究组 & 干预措施
Empagliflozin
12 week treatment with 10mg empagliflozin daily
干预措施: Empagliflozin (Drug)
Placebo
12 week treatment with 10mg placebo daily
干预措施: Placebo (Drug)
结局指标
主要结局
Carotid-femoral Pulse Wave Velocity (cfPWV)
时间窗: baseline (t0), week 4, week 8, 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.
次要结局
未报告次要终点