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Completed

NCT Number: NCT01475513

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

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.

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Key information

Conditions

Insulin Sensitivity Cardiovascular Risk Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases Perimenopausal Disorder

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Virginia Commonwealth University Medical Center

Richmond, Virginia, 23298-0111, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Orthocyclen, Sprintec, Previfem, MonoNessa

Primary outcomes

  1. 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

  2. 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

  3. 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

  1. Change From Baseline in Acute Insulin Response to Glucose

    Time frame: Baseline, 6 months

    Acute Insulin Response to Glucose values obtained from FSIVGTT models--higher values indicate better insulin response

  2. Change From Baseline in Glucose Effectiveness

    Time frame: Baseline, 6 months

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

  3. Change From Baseline in Disposition Index at 6 Months

    Time frame: Baseline, 6 months

    Modeled from FISVGTT--higher values indicate better glucose disposition

  4. Change From Baseline in Fasting Insulin at 6 Months

    Time frame: Baseline, 6 months

    Higher fasting insulin values indicate an increased metabolic risk

  5. Change From Baseline in Fasting Glucose at 6 Months

    Time frame: Baseline, 6 months

    Higher fasting glucose indicate an increased metabolic risk

  6. Change From Baseline in Areas-under-the-curve for Insulin at 6 Months

    Time frame: Baselines, 6 months

    Measured during oral glucose tolerance test. Higher values indicate increased metabolic risk

  7. Change From Baseline in Areas-under-the-curve for Glucose

    Time frame: Baseline, 6 months

    Measured during oral glucose tolerance test. Higher values indicate increased metabolic risk

  8. Change From Baseline in Systolic Blood Pressure at 6 Months

    Time frame: Baseline, 6 months

    Higher value indicates increased cardiovascular risk

  9. Change From Baseline in HDL at 6 Months

    Time frame: Baseline, 6 months

    Lower values indicate increased cardiovascular risk

  10. Change From Baseline in Body Mass Index in 6 Months

    Time frame: Baseline, 6 months

    Higher values indicate higher metabolic risk

  11. Change in Diastolic Blood Pressure From Baseline to 6 Months

    Time frame: Baseline, 6 months

    Higher value indicates higher cardiovascular risk

  12. Change in LDL From Baseline to 6 Months

    Time frame: Baseline, 6 months

    Higher value indicates higher cardiovascular risk

  13. Change in Triglycerides From Baseline to 6 Months

    Time frame: Baseline, 6 months

    Higher values indicate higher cardiovascular risk

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Collaborators

  • American Heart Association

Registry information

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Nov 21, 2011
Registry last updated
Aug 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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