Mineralocorticoid Receptor and Obesity Induced Cardiovascular Complications
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Change From Baseline in Post-ischemic Dilatation
研究概览
简要总结
The purpose of this study is to find out if spironolactone, a drug that blocks the action of aldosterone, can make the blood vessels work better in people with obesity. The investigators also want to find out whether spironolactone causes changes in levels of insulin and markers of inflammation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-70 years
- •Good health as evidenced by history and physical exam
- •Body Mass Index (BMI): >30 kg/m2 and <45 kg/m2
- •Exclusion criteria:
- •Medical illnesses other than treated hypothyroidism
- •Blood Pressure (BP) >135/85 or systolic BP <90 mm Hg
- •Hepatic disease (transaminase > 3 times normal)
- •Renal impairment (Creatinine clearance <60 ml/min)
- •Baseline serum Potassium (K) >5.0 mmol/L
- •History of drug or alcohol abuse
- •Allergies to spironolactone
- •Participation in any other concurrent clinical trial
- •Women using oral contraceptives within the last 3 months
排除标准
- 未提供
研究组 & 干预措施
Spironolactone
干预措施: Spironolactone (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Post-ischemic Dilatation
时间窗: Baseline and Week 6
Ultrasonography of the brachial artery was performed to evaluate endothelial function by flow mediated dilatation (FMD) studies. A blood pressure cuff was placed on the participant's upper arm and was compressed for 5 minutes. After release of compression, brachial artery diameter and blood flow velocity were measured. FMD was expressed as the percentage change in brachial artery diameter. A positive change from Baseline indicates improvement.
次要结局
- Change From Baseline in Para-aminohippurate (PAH) Clearance(Baseline and Week 6 (Prior to PAH infusion and at 50 and 60 minutes post PAH infusion))
- Change From Baseline in Markers of Inflammation(Baseline and Week 6)
- Change From Baseline in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)(Baseline and Week 6 (Prior to ingesting glucose and every 30 minutes for 120 minutes))
- Change From Baseline in Insulin Sensitivity Index (ISI)(Baseline and Week 6 (Prior to ingesting glucose and every 30 minutes for 120 minutes))
研究者
Rajesh K. Garg
Associate Physician
Brigham and Women's Hospital