Oral Contraceptives, Insulin Resistance and Cardiovascular Risk Profile in Pre-Menopausal Women

Phase 4

Completed

Conditions: Insulin Sensitivity
Perimenopausal Disorder
Cardiovascular Risk

Interventions: Drug: Ortho Cyclen®

Registration Number: NCT01475513

Lead Sponsor: Virginia Commonwealth University

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 47

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

Diabetes
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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
African-American women	Ortho Cyclen®	African-American women
Caucasian women	Ortho Cyclen®	Caucasian women

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Flow-mediated Vasodilatation	Baseline, 6 months	Change Flow-mediated Vasodilatation from baseline to 6 months. Higher values indicate less cardiovascular risk
Change From Baseline in Insulin Sensitivity	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	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 Outcome Measures

Name	Time	Method
Change From Baseline in Disposition Index at 6 Months	Baseline, 6 months	Modeled from FISVGTT--higher values indicate better glucose disposition
Change in Triglycerides From Baseline to 6 Months	Baseline, 6 months	Higher values indicate higher cardiovascular risk
Change From Baseline in HDL at 6 Months	Baseline, 6 months	Lower values indicate increased cardiovascular risk
Change From Baseline in Glucose Effectiveness	Baseline, 6 months	Obtained from FSIVGTT models--higher values indicate better effectiveness of glucose inducing its own disposition
Change From Baseline in Fasting Insulin at 6 Months	Baseline, 6 months	Higher fasting insulin values indicate an increased metabolic risk
Change From Baseline in Fasting Glucose at 6 Months	Baseline, 6 months	Higher fasting glucose indicate an increased metabolic risk
Change From Baseline in Areas-under-the-curve for Glucose	Baseline, 6 months	Measured during oral glucose tolerance test. Higher values indicate increased metabolic risk
Change From Baseline in Body Mass Index in 6 Months	Baseline, 6 months	Higher values indicate higher metabolic risk
Change in Diastolic Blood Pressure From Baseline to 6 Months	Baseline, 6 months	Higher value indicates higher cardiovascular risk
Change From Baseline in Acute Insulin Response to Glucose	Baseline, 6 months	Acute Insulin Response to Glucose values obtained from FSIVGTT models--higher values indicate better insulin response
Change in LDL From Baseline to 6 Months	Baseline, 6 months	Higher value indicates higher cardiovascular risk
Change From Baseline in Areas-under-the-curve for Insulin at 6 Months	Baselines, 6 months	Measured during oral glucose tolerance test. Higher values indicate increased metabolic risk
Change From Baseline in Systolic Blood Pressure at 6 Months	Baseline, 6 months	Higher value indicates increased cardiovascular risk