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

Insulin Sensitivity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01475513
• Other study ID #: HM13769
• Status: Completed
• Phase: Phase 4
• Start date: November 2011
• Est. completion date: May 28, 2014

Study information

• Verified date: July 2018
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: May 28, 2014
• Est. primary completion date: May 28, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Risk
• Hypersensitivity
• Insulin Resistance
• Insulin Sensitivity
• Perimenopausal Disorder

Intervention

Drug:
• Ortho Cyclen®
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.

Locations

Country	Name	City	State
United States	Virginia Commonwealth University Medical Center	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	American Heart Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	Change From Baseline in Glucose Effectiveness	Obtained from FSIVGTT models--higher values indicate better effectiveness of glucose inducing its own disposition	Baseline, 6 months
Secondary	Change From Baseline in Disposition Index at 6 Months	Modeled from FISVGTT--higher values indicate better glucose disposition	Baseline, 6 months
Secondary	Change From Baseline in Fasting Insulin at 6 Months	Higher fasting insulin values indicate an increased metabolic risk	Baseline, 6 months
Secondary	Change From Baseline in Fasting Glucose at 6 Months	Higher fasting glucose indicate an increased metabolic risk	Baseline, 6 months
Secondary	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
Secondary	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
Secondary	Change From Baseline in Systolic Blood Pressure at 6 Months	Higher value indicates increased cardiovascular risk	Baseline, 6 months
Secondary	Change From Baseline in HDL at 6 Months	Lower values indicate increased cardiovascular risk	Baseline, 6 months
Secondary	Change From Baseline in Body Mass Index in 6 Months	Higher values indicate higher metabolic risk	Baseline, 6 months
Secondary	Change in Diastolic Blood Pressure From Baseline to 6 Months	Higher value indicates higher cardiovascular risk	Baseline, 6 months
Secondary	Change in LDL From Baseline to 6 Months	Higher value indicates higher cardiovascular risk	Baseline, 6 months
Secondary	Change in Triglycerides From Baseline to 6 Months	Higher values indicate higher cardiovascular risk	Baseline, 6 months