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

Virginia Commonwealth University47 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

SCREENING

Masking

NONE

Enrollment

Conditions

Insulin Sensitivity Cardiovascular Risk Perimenopausal Disorder

Interventions

Ortho Cyclen®DRUG

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Virginia Commonwealth University Medical Center

Richmond, Virginia, United States

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: baseline, 6 months

Secondary Outcomes

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

Time frame: Baseline, 6 months

Change From Baseline in Glucose Effectiveness

Obtained from FSIVGTT models--higher values indicate better effectiveness of glucose inducing its own disposition

Time frame: Baseline, 6 months

Change From Baseline in Disposition Index at 6 Months

Modeled from FISVGTT--higher values indicate better glucose disposition

Time frame: Baseline, 6 months

Change From Baseline in Fasting Insulin at 6 Months

Higher fasting insulin values indicate an increased metabolic risk

Data from ClinicalTrials.gov

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