Oral Contraceptives, Insulin Resistance and Cardiovascular Risk Profile in Pre-Menopausal Women
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Change From Baseline in Flow-mediated Vasodilatation
研究概览
简要总结
Birth control pills are the most commonly used method of birth control. The purpose of this research study is to examine whether birth control pills change heart disease risk and how the body handles blood sugar when given to different women.
详细描述
The oral contraceptive pill is the most commonly used birth control method. It is debated whether the birth control pill affects how the body handles insulin and sugar, or whether the pill changes heart disease risk. The goal of this study is to evaluate whether certain factors, such as how the body processes hormones, and demographic factors (e.g. body weight and race), influence how the pill affects the handling of insulin and sugar, and heart health.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Premenopausal, regular-cycling women 18-35 years
- •Either African-American or Caucasian (African-American and Caucasian women will be BMI-matched)
- •non-smoker.
排除标准
- •Clinically significant pulmonary, cardiac, renal, hepatic, neurologic, psychiatric, infectious, and malignant disease
- •Contraindications to oral contraceptive use (history of blood clots, heart attacks or stroke, vascular disease, coagulopathy, prolonged immobilization, breast cancer, migraine head-aches, major surgery within past 6 months, blood pressure >160/100 mmHg, pregnancy or lactation)
- •Use of hormonal contraceptives, glucose-lowering medications, anti-hyperlipidemic, anti-hypertensive or other vasoactive drugs within previous 3 months
研究组 & 干预措施
African-American women
African-American women
干预措施: Ortho Cyclen® (Drug)
Caucasian women
Caucasian women
干预措施: Ortho Cyclen® (Drug)
结局指标
主要结局
Change From Baseline in Flow-mediated Vasodilatation
时间窗: Baseline, 6 months
Change Flow-mediated Vasodilatation from baseline to 6 months. Higher values indicate less cardiovascular risk
Change From Baseline in Insulin Sensitivity
时间窗: Baseline, 6 months
Insulin sensitivity from Frequently sampled IV glucose tolerance test (FSIVGTT), change from baseline to 6 months. Higher values indicate better insulin sensitivity
Change From Baseline in Carotid Intima Media Thickness
时间窗: baseline, 6 months
Change in Carotid Intima Media Thickness from baseline to 6 months, measured on the right carotid artery, posterior. Lower values indicate better cardiovascular risk profile
次要结局
- Change From Baseline in Disposition Index at 6 Months(Baseline, 6 months)
- Change in Triglycerides From Baseline to 6 Months(Baseline, 6 months)
- Change From Baseline in HDL at 6 Months(Baseline, 6 months)
- Change From Baseline in Glucose Effectiveness(Baseline, 6 months)
- Change From Baseline in Fasting Insulin at 6 Months(Baseline, 6 months)
- Change From Baseline in Fasting Glucose at 6 Months(Baseline, 6 months)
- Change From Baseline in Areas-under-the-curve for Glucose(Baseline, 6 months)
- Change From Baseline in Body Mass Index in 6 Months(Baseline, 6 months)
- Change in Diastolic Blood Pressure From Baseline to 6 Months(Baseline, 6 months)
- Change From Baseline in Acute Insulin Response to Glucose(Baseline, 6 months)
- Change in LDL From Baseline to 6 Months(Baseline, 6 months)
- Change From Baseline in Areas-under-the-curve for Insulin at 6 Months(Baselines, 6 months)
- Change From Baseline in Systolic Blood Pressure at 6 Months(Baseline, 6 months)