Oral Contraceptives, Insulin Resistance and Cardiovascular Risk Profile in Pre-Menopausal Women
Overview
- Phase
- Phase 4
- Intervention
- Ortho Cyclen®
- Conditions
- Insulin Sensitivity
- Sponsor
- Virginia Commonwealth University
- Enrollment
- 47
- Locations
- 1
- Primary Endpoint
- Change From Baseline in Flow-mediated Vasodilatation
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Premenopausal, regular-cycling women 18-35 years
- •Either African-American or Caucasian (African-American and Caucasian women will be BMI-matched)
- •non-smoker.
Exclusion Criteria
- •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
Arms & Interventions
African-American women
African-American women
Intervention: Ortho Cyclen®
Caucasian women
Caucasian women
Intervention: Ortho Cyclen®
Outcomes
Primary Outcomes
Change From Baseline in Flow-mediated Vasodilatation
Time Frame: Baseline, 6 months
Change Flow-mediated Vasodilatation from baseline to 6 months. Higher values indicate less cardiovascular risk
Change From Baseline in Insulin Sensitivity
Time Frame: 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
Time Frame: 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
Secondary Outcomes
- 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)