NCT00775671已完成4 期
Comparative Effect of Nebivolol vs. Metoprolol on Insulin Sensitivity and Fibrinolytic Balance in Metabolic Syndrome
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Marker of Fibrinolysis
研究概览
简要总结
Test the hypothesis that nebivolol treatment improves fibrinolytic balance and insulin sensitivity compared to metoprolol treatment in individuals with metabolic syndrome.
详细描述
- Test the hypothesis that nebivolol treatment decreases PAI-1 antigen and activity and improves fibrinolytic balance compared to metoprolol treatment in individuals with metabolic syndrome.
- Test the hypothesis that nebivolol treatment improves insulin sensitivity compared to metoprolol treatment in individuals with metabolic syndrome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 是
入选标准
- •Ambulatory subjects, 18 to 70 years of age, inclusive
- •For female subjects, the following conditions must be met:
- •postmenopausal status for at least 1 year, or
- •status-post surgical sterilization, or
- •if of childbearing potential, utilization of adequate birth control and willingness to undergo urine beta-hcg testing prior to drug treatment and on every study day
- •Metabolic syndrome as defined by 3 or more of the following:
- •Fasting plasma glucose of at least 100 mg/dL (5.5 mmol/L)
- •Serum triglycerides of at least 150 mg/dL (1.7 mmol/L)
- •Serum HDL cholesterol less than 40 mg/dL (1.04 mmol/L) in men and 50 mg/dL in women
- •Blood pressure of at least 130/85 mmHg
- •Waist girth of more than 102 cm in men or 88 cm in women
排除标准
- •Subjects presenting with any of the following will not be included in the study:
- •Diabetes type 1 or type 2, as defined by a fasting glucose of 126 mg/dL or greater or the use of anti-diabetic medication
- •Use of hormone replacement therapy
- •Change in statin therapy within the last 6 months
- •In hypertensive subjects, a seated systolic blood pressure greater than 179 mmHg or a seated diastolic blood pressure greater than 110 mmHg
- •Breast-feeding
- •Cardiovascular disease 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
- •Treatment with anticoagulants
- •History of serious neurologic disease such as cerebral hemorrhage, stroke, or transient ischemic attack
- •History or presence of immunological or hematological disorders
- •Diagnosis of asthma
- •Clinically significant gastrointestinal impairment that could interfere with drug absorption
- •Impaired hepatic function (aspartate amino transaminase [AST] and/or alanine amino transaminase [ALT] >2.0 x upper limit of normal range)
- •Impaired renal function (serum creatinine >1.5 mg/dl)
- •Hematocrit <35%
- •Any underlying or acute disease requiring regular medication which could possibly pose a threat to the subject or make implementation of the protocol or interpretation of the study results difficult
- •Treatment with chronic systemic glucocorticoid therapy (more than 7 consecutive days in 1 month)
- •Treatment with lithium salts
- •History of alcohol or drug abuse
- •Treatment with any investigational drug in the 1 month preceding the study
- •Mental conditions rendering the subject unable to understand the nature, scope and possible consequences of the study
- •Inability to comply with the protocol, e.g. uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study
- •Inability to swallow capsules
研究组 & 干预措施
Nebivolol
Active Comparator
Nebivolol 5mg by mouth daily for 12 weeks.
干预措施: placebo (Drug)
Nebivolol
Active Comparator
Nebivolol 5mg by mouth daily for 12 weeks.
干预措施: Nebivolol (Drug)
Metoprolol
Active Comparator
Metoprolol ER 100mg by mouth daily for 12 weeks.
干预措施: placebo (Drug)
Metoprolol
Active Comparator
Metoprolol ER 100mg by mouth daily for 12 weeks.
干预措施: Metoprolol (Drug)
结局指标
主要结局
Marker of Fibrinolysis
时间窗: After 12 weeks of study drug
Concentration of plasminogen activator inhibitor 1 (PAI-1)antigen.
次要结局
- Measurement of Insulin Sensitivity(3 hours)
研究者
Nancy J. Brown
Professor of Medicine and Pharmacology
Vanderbilt University
研究点 (1)
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