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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Insulin Sensitivity, Cardiovascular Risk, Perimenopausal Disorder

Intervention / Treatment
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* Drug: Ortho Cyclen®


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Same drug (orthocyclen) was administered to 2 groups (Caucasian women of reproductive age, and African American women of reproductive age)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: African-American women<br>African-American women | Drug: Ortho Cyclen®<br>* Ethinyl estradiol 35 mcg and norgestimate 0.25 mg (oral) will be taken as one tablet daily for 21 days per month followed by a 7-day pill-free period per cycle. Duration of the study is for 6 cycles of this birth control pill.<br>* Other names: MonoNessa;|
| Active Comparator: Caucasian women<br>Caucasian women | Drug: Ortho Cyclen®<br>* Ethinyl estradiol 35 mcg and norgestimate 0.25 mg (oral) will be taken as one tablet daily for 21 days per month followed by a 7-day pill-free period per cycle. Duration of the study is for 6 cycles of this birth control pill.<br>* Other names: MonoNessa;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Insulin Sensitivity | Insulin sensitivity from Frequently sampled IV glucose tolerance test (FSIVGTT), change from baseline to 6 months. Higher values indicate better insulin sensitivity | Baseline, 6 months | 
| Change From Baseline in Flow-mediated Vasodilatation | Change Flow-mediated Vasodilatation from baseline to 6 months. Higher values indicate less cardiovascular risk | Baseline, 6 months | 
| Change From Baseline in Carotid Intima Media Thickness | 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 | baseline, 6 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oral contraceptive, birth control pill, women, healthy volunteer, insulin sensitivity, insulin resistance, cardiovascular risk factors, endothelial function, estrogen metabolism, racial difference, glucose intolerance