Clinical trial NCT01475513: Oral Contraceptives, Insulin Resistance and Cardiovascular Risk Profile in Pre-Menopausal Women
Official title: Oral Contraceptives, Insulin Resistance and Cardiovascular Risk Profile in Pre-Menopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Insulin Sensitivity
Cardiovascular Risk
Perimenopausal Disorder
Keywords: oral contraceptive
birth control pill
women
healthy volunteer
insulin sensitivity
insulin resistance
cardiovascular risk factors
endothelial function
estrogen metabolism
racial difference
glucose intolerance
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2011-11-21
Enrollment: 47
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Same drug (orthocyclen) was administered to 2 groups (Caucasian women of reproductive age, and African American women of reproductive age)
Primary purpose: SCREENING

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.

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:

* 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

Primary outcomes:
measure: Change From Baseline in Insulin Sensitivity
timeFrame: Baseline, 6 months
measure: Change From Baseline in Flow-mediated Vasodilatation
timeFrame: Baseline, 6 months
measure: Change From Baseline in Carotid Intima Media Thickness
timeFrame: baseline, 6 months
Secondary outcomes:
measure: Change From Baseline in Acute Insulin Response to Glucose
timeFrame: Baseline, 6 months
measure: Change From Baseline in Glucose Effectiveness
timeFrame: Baseline, 6 months
measure: Change From Baseline in Disposition Index at 6 Months
timeFrame: Baseline, 6 months
measure: Change From Baseline in Fasting Insulin at 6 Months
timeFrame: Baseline, 6 months
measure: Change From Baseline in Fasting Glucose at 6 Months
timeFrame: Baseline, 6 months
measure: Change From Baseline in Areas-under-the-curve for Insulin at 6 Months
timeFrame: Baselines, 6 months
measure: Change From Baseline in Areas-under-the-curve for Glucose
timeFrame: Baseline, 6 months
measure: Change From Baseline in Systolic Blood Pressure at 6 Months
timeFrame: Baseline, 6 months
measure: Change From Baseline in HDL at 6 Months
timeFrame: Baseline, 6 months
measure: Change From Baseline in Body Mass Index in 6 Months
timeFrame: Baseline, 6 months
measure: Change in Diastolic Blood Pressure From Baseline to 6 Months
timeFrame: Baseline, 6 months
measure: Change in LDL From Baseline to 6 Months
timeFrame: Baseline, 6 months
measure: Change in Triglycerides From Baseline to 6 Months
timeFrame: Baseline, 6 months
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University Medical Center
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Kai Cheang, Pharm. D.
role: PRINCIPAL_INVESTIGATOR
References: