Back to resultsOral Contraceptives, Insulin Resistance and Cardiovascular Risk Profile in Pre-Menopausal Women
Primary Purpose
Insulin Sensitivity, Cardiovascular Risk, Perimenopausal Disorder
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ortho Cyclen®
Sponsored by
About this trial
This is an interventional screening trial for Insulin Sensitivity focused on measuring oral contraceptive, birth control pill, women, healthy volunteer, insulin sensitivity, insulin resistance, cardiovascular risk factors, endothelial function, estrogen metabolism, racial difference, glucose intolerance
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
Sites / Locations
- Virginia Commonwealth University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
African-American women
Caucasian women
Arm Description
African-American women
Caucasian women
Outcomes
Primary Outcome Measures
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
Change From Baseline in Flow-mediated Vasodilatation
Change Flow-mediated Vasodilatation from baseline to 6 months. Higher values indicate less cardiovascular risk
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
Secondary Outcome Measures
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
Change From Baseline in Glucose Effectiveness
Obtained from FSIVGTT models--higher values indicate better effectiveness of glucose inducing its own disposition
Change From Baseline in Disposition Index at 6 Months
Modeled from FISVGTT--higher values indicate better glucose disposition
Change From Baseline in Fasting Insulin at 6 Months
Higher fasting insulin values indicate an increased metabolic risk
Change From Baseline in Fasting Glucose at 6 Months
Higher fasting glucose indicate an increased metabolic risk
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
Change From Baseline in Areas-under-the-curve for Glucose
Measured during oral glucose tolerance test. Higher values indicate increased metabolic risk
Change From Baseline in Systolic Blood Pressure at 6 Months
Higher value indicates increased cardiovascular risk
Change From Baseline in HDL at 6 Months
Lower values indicate increased cardiovascular risk
Change From Baseline in Body Mass Index in 6 Months
Higher values indicate higher metabolic risk
Change in Diastolic Blood Pressure From Baseline to 6 Months
Higher value indicates higher cardiovascular risk
Change in LDL From Baseline to 6 Months
Higher value indicates higher cardiovascular risk
Change in Triglycerides From Baseline to 6 Months
Higher values indicate higher cardiovascular risk
Full Information
NCT ID
NCT01475513
First Posted
November 8, 2011
Last Updated
July 10, 2018
Sponsor
Virginia Commonwealth University
Collaborators
American Heart Association
1. Study Identification
Unique Protocol Identification Number
NCT01475513
Brief Title
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
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
May 28, 2014 (Actual)
Study Completion Date
May 28, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
Collaborators
American Heart Association
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Screening
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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)
Allocation
Non-Randomized
Enrollment
47 (Actual)
8. Arms, Groups, and Interventions
Arm Title
African-American women
Arm Type
Active Comparator
Arm Description
African-American women
Arm Title
Caucasian women
Arm Type
Active Comparator
Arm Description
Caucasian women
Intervention Type
Drug
Intervention Name(s)
Ortho Cyclen®
Other Intervention Name(s)
Orthocyclen, Sprintec, Previfem, MonoNessa
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change From Baseline in Insulin Sensitivity
Description
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
Title
Change From Baseline in Flow-mediated Vasodilatation
Description
Change Flow-mediated Vasodilatation from baseline to 6 months. Higher values indicate less cardiovascular risk
Time Frame
Baseline, 6 months
Title
Change From Baseline in Carotid Intima Media Thickness
Description
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 Outcome Measure Information:
Title
Change From Baseline in Acute Insulin Response to Glucose
Description
Acute Insulin Response to Glucose values obtained from FSIVGTT models--higher values indicate better insulin response
Time Frame
Baseline, 6 months
Title
Change From Baseline in Glucose Effectiveness
Description
Obtained from FSIVGTT models--higher values indicate better effectiveness of glucose inducing its own disposition
Time Frame
Baseline, 6 months
Title
Change From Baseline in Disposition Index at 6 Months
Description
Modeled from FISVGTT--higher values indicate better glucose disposition
Time Frame
Baseline, 6 months
Title
Change From Baseline in Fasting Insulin at 6 Months
Description
Higher fasting insulin values indicate an increased metabolic risk
Time Frame
Baseline, 6 months
Title
Change From Baseline in Fasting Glucose at 6 Months
Description
Higher fasting glucose indicate an increased metabolic risk
Time Frame
Baseline, 6 months
Title
Change From Baseline in Areas-under-the-curve for Insulin at 6 Months
Description
Measured during oral glucose tolerance test. Higher values indicate increased metabolic risk
Time Frame
Baselines, 6 months
Title
Change From Baseline in Areas-under-the-curve for Glucose
Description
Measured during oral glucose tolerance test. Higher values indicate increased metabolic risk
Time Frame
Baseline, 6 months
Title
Change From Baseline in Systolic Blood Pressure at 6 Months
Description
Higher value indicates increased cardiovascular risk
Time Frame
Baseline, 6 months
Title
Change From Baseline in HDL at 6 Months
Description
Lower values indicate increased cardiovascular risk
Time Frame
Baseline, 6 months
Title
Change From Baseline in Body Mass Index in 6 Months
Description
Higher values indicate higher metabolic risk
Time Frame
Baseline, 6 months
Title
Change in Diastolic Blood Pressure From Baseline to 6 Months
Description
Higher value indicates higher cardiovascular risk
Time Frame
Baseline, 6 months
Title
Change in LDL From Baseline to 6 Months
Description
Higher value indicates higher cardiovascular risk
Time Frame
Baseline, 6 months
Title
Change in Triglycerides From Baseline to 6 Months
Description
Higher values indicate higher cardiovascular risk
Time Frame
Baseline, 6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kai Cheang, Pharm. D.
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298-0111
Country
United States
12. IPD Sharing Statement
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Oral Contraceptives, Insulin Resistance and Cardiovascular Risk Profile in Pre-Menopausal Women
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