Effects and Mechanisms of Melatonin on Blood Pressure, Insulin Resistance, and Platelets
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Office Systolic Blood pressure change
研究概览
简要总结
The investigators will be studying the effect of melatonin on blood pressure, insulin resistance, and platelets, along with possible reasons for how melatonin cases these effects.
详细描述
The investigators will be studying the effect of melatonin on blood pressure and insulin resistance, and possible reasons for how melatonin works on blood pressure and IR. Along with blood testing to measure adipokines, insulin resistance (IR), and platelet function (how well your blood clots), 24-hour ambulatory blood pressure monitoring (ABPM) will be used to measure blood pressure, since ABPM is the gold standard (best method) for accurate assessment of blood pressure status and associated cardiovascular risk. Vascular (blood vessel) function, IR, adipokine levels and sleep quality will also be measured. All study endpoints will be measured at baseline and following 6 weeks of daily melatonin 9 mg dosing.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Normotensive (SBP <120) or prehypertensive (SBP = 120-139 mm Hg)
- •Age: Young/middle-aged (ages 18-45) and (2) 10 elderly subjects ages 65 and older
排除标准
- •Patients with a diagnosis of
- •clinical hypertension and/or diabetes mellitus
- •pregnancy
- •coronary or cerebrovascular disease
- •collagen vascular disease,
- •organ failure (heart, kidney, liver).
- •Patients taking anti-inflammatory medications: NSAIDs, corticosteroids, thiazolidinediones, and statins,
- •Patients who have taken melatonin previously in the past year.
结局指标
主要结局
Office Systolic Blood pressure change
时间窗: Baseline to 6 weeks
Change in Systolic blood pressure measured in the office at 6 weeks
Ambulatory Diastolic Blood pressure change
时间窗: Baseline to 6 weeks
Change in 24 hour average Diastolic blood pressure at 6 weeks
QUICKI: Quantitative insulin sensitivity check index change
时间窗: Baseline to 6 weeks
Insulin sensitivity measure change at 6 weeks
Office Diastolic Blood pressure change
时间窗: Baseline to 6 weeks
Change in Diastolic blood pressure measured in the office at 6 weeks
Ambulatory Systolic Blood pressure change
时间窗: Baseline to 6 weeks
Change in 24 hour average Systolic blood pressure at 6 weeks
HOMA: Homeostasis Model Assessment change
时间窗: Baseline to 6 weeks
Insulin sensitivity measure change at 6 weeks
次要结局
- Arachidonic acid stimulated aggregation change(Baseline to 6 weeks)