Sympathetic Mechanisms in the Cardiovascular and Metabolic Alterations of Obesity, Crossover Design Study.
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Endogenous glucose production
研究概览
简要总结
We will study obese hypertensive subjects in a randomized, crossover study to determine if two weeks sympathetic blockade improves endogenous glucose production. Subjects will be studied on 3 different occasions after two weeks of receiving either placebo, amlodipine (vasodilator arm) or moxonidine (study arm). The order of the studies will be determined using computer-generated randomization. Patients will be blinded as to which treatment they are receiving on each day. An investigator blinded to the treatment assignment will perform the analysis of the data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females of all races between 18 and 65 years of age
- •Hypertension defined by two or more properly measured seated blood pressure readings >130/85 mmHg or currently on antihypertensive medication.
- •Obesity will be defined as having a body mass index (BMI) ≥ 30 kg/m
- •Able and willing to provide informed consent.
排除标准
- •Pregnancy or breast feeding
- •Current smokers or history of heavy smoking (>2 packs/day)
- •History of alcohol or drug abuse
- •Previous allergic reaction to study medications
- •Type I diabetes.
- •Cardiovascular disease other than hypertension such as myocardial infarction within 6 months prior to enrollment, presence of angina pectoris, significant arrhythmia, congestive heart failure (LV hypertrophy acceptable), deep vein thrombosis, pulmonary embolism, second or third degree heart block, mitral valve stenosis, aortic stenosis, or hypertrophic cardiomyopathy
- •History of serious cerebrovascular disease such as cerebral hemorrhage, stroke, or transient ischemic attack
- •History or presence of immunological or hematological disorders
- •Impaired renal function
- •Treatment with chronic systemic glucocorticoid therapy (more than 7 consecutive days in 1 month)
- •Treatment with any investigational drug in the 1 month preceding the study
- •Inability to give, or withdraw, informed consent
- •Other factors which in the investigator's opinion would prevent the subject from completing the protocol (i.e., clinically significant abnormalities on clinical, mental examination or laboratory testing or inability to comply with protocol, inability to find IV access)
研究组 & 干预措施
Placebo
Subjects will received 2 weeks of capsules containing placebo.
干预措施: Placebo (Drug)
Amlodipine
Subjects will received 2 weeks of capsules containing amlodipine.
干预措施: Amlodipine (Drug)
Moxonidine
Subjects will received 2 weeks of capsules containing moxonidine.
干预措施: Moxonidine (Drug)
结局指标
主要结局
Endogenous glucose production
时间窗: During two-step insulin clamp (six hours)
Rate of appearance and disappearance of labeled glucose
次要结局
未报告次要终点
研究者
Italo Biaggioni
Professor of Medicine
Vanderbilt University Medical Center