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Oral Contraceptives in the Metabolic Syndrome
This study is currently recruiting participants.
Verified by Virginia Commonwealth University, July 2007
Sponsored by: Virginia Commonwealth University
Information provided by: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT00205504
  Purpose

Oral contraceptives (OCs) are the most widely used method of reversible birth control. However, the long-term cardiovascular safety of the widely used low-dose OCs (ethinyl-estradiol < 50 mcg) is still debated. Although cardiovascular events are rare in young women whether they use OCs or not, the risks of myocardial infarction and ischemic stroke are increased among users of OCs who have conventional cardiovascular risk factors such as use of tobacco, diabetes or hypercholesterolemia. However, the risk of cardiovascular events in OC users with emerging cardiovascular risk factors have not been investigated. One such emerging cardiovascular risk factor is the metabolic syndrome. Recently, the metabolic syndrome has been linked with the risk of cardiovascular disease. The syndrome is a clustering of risk factors in a single individual, and its underlying cause may be insulin resistance. Whether the metabolic syndrome predicts a higher cardiovascular risk in OC users has not been studied. This is a critical problem because the metabolic syndrome is prevalent in 24% of adults. Until the cardiovascular risks in users of OC are clearly defined, the appropriate use of OC with the least harm would not be possible.

The investigator's long-term goal is to understand the best way to prevent and treat cardiovascular disease in women. The objective of this particular project is to obtain pilot data on the extent to which the metabolic syndrome affects cardiovascular risks in women taking OCs. The researchers hypothesize that the metabolic syndrome predicts higher cardiovascular risks in OC users. Results of this study will clarify the risk factors for cardiovascular events in women taking OCs, and will serve as pilot data for a National Institutes of Health (NIH) proposal. Once the cardiovascular risk factors of OC users are understood, clinicians can make better informed decisions about contraceptive choices for their patients.


Condition Intervention Phase
Metabolic Syndrome X
Insulin Resistance
Obesity
Cardiovascular Diseases
Drug: Ortho Tri Cyclen
Phase IV

MedlinePlus related topics: Metabolic Syndrome Obesity
Drug Information available for: Moxifloxacin Moxifloxacin hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety Study
Official Title: Oral Contraceptives in the Metabolic Syndrome

Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • Difference in insulin sensitivity changes associated with oral contraceptive use compared between women with the metabolic syndrome and women without the metabolic syndrome
  • Difference in inflammatory marker changes (e.g. CRP, PAI-1, tPA, adiponectin, VCAM, ICAM, and others) associated with oral contraceptive use compared between women with the metabolic syndrome and women without the metabolic syndrome

Secondary Outcome Measures:
  • Changes in lipid profile, blood pressure, weight, waist-hip ratio and other athropometric measures associated with oral contraceptive use between women with and without the metabolic syndrome

Estimated Enrollment: 40
Study Start Date: June 2005
Estimated Study Completion Date: November 2008
  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Acceptable health based on interview, medical history, physical examination, and laboratory tests (SMA20 and CBC);
  2. Have not taken OCs in the past year;
  3. Ability to comply with the requirements of the study;
  4. Ability and willingness to provide signed, witnessed informed consent. In addition, women with the metabolic syndrome must meet the National Cholesterol Education Program (NCEP) defined criteria of the metabolic syndrome, that is, having at least 3 of the 5 factors:

    1. increased waist circumference > 35 inches,
    2. hypertriglyceridemia ≥ 150 mg/dL,
    3. low HDL cholesterol < 50 mg/dL in women,
    4. hypertension (≥ 130/≥ 85 mmHg),
    5. fasting glucose ≥ 100 mg/dL.

To eliminate weight as a confounding factor in the study, women in the control group without the metabolic syndrome should have an increased waist circumference > 35 inches or a body mass index (BMI) > 26.7kg/m2, a value that corresponds to a waist circumference of 35 inches.

10 lean normal weight women (BMI <= 25 kg/m2) will serve as a comparison group.

Exclusion Criteria:

  1. Diabetes mellitus by fasting glucose or a 2-hour oral glucose tolerance test (OGTT);
  2. Clinically significant pulmonary, cardiac (including but not limited to ischemic heart disease, stable/unstable angina, and congestive heart failure), renal, hepatic, cholestatic, neurologic, psychiatric, infectious, and malignant disease (other than melanoma skin cancer);
  3. History of thromboembolism, myocardial infarction, cerebrovascular accident, vascular disease, known coagulopathy, prolonged immobilization, or recent major surgery (within past 6 months);
  4. Systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than 100 mmHg (mild hypertension is not an exclusion criterion);
  5. History of breast cancer, migraine headaches, or age ≥ 35 years and smoker of ≥ 20 cigarettes/day;
  6. Use of metformin, thiazolidinediones, anti-hyperlipidemic drugs, anti-hypertensive drugs, glucocorticoids, or anti-androgens (spironolactone, flutamide, etc.) within 3 months;
  7. Documented or suspected illicit drug abuse or alcoholism within one year;
  8. Ingestion of any investigational drugs within 3 months prior to the study onset; and
  9. Pregnancy or lactation (≤ 6 weeks postpartum);
  10. Hematocrit < 33g/dL. These exclusion criteria are based on study requirements and also go beyond guidelines for OC use published by the World Health Organization.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00205504

Contacts
Contact: Kai I Cheang, Pharm.D. 804-828-9698 kicheang@vcu.edu

Locations
United States, Virginia
Virginia Commonwealth University General Clinical Research Center Recruiting
Richmond, Virginia, United States, 23298
Contact: Kai I Cheang, Pharm.D.     804-828-9698     kicheang@vcu.edu    
Principal Investigator: Kai I Cheang, Pharm.D.            
Sub-Investigator: John E Nestler, M.D.            
Sub-Investigator: Paulina A Essah, M.D.            
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
Principal Investigator: Kai I Cheang, Pharm.D. Virginia Commonwealth University
Study Director: John E Nestler, M.D. Virginia Commonwealth University
Study Director: Paulina A Essah, M.D. Virginia Commonwealth University
  More Information

Study ID Numbers: AD Williams
Study First Received: September 13, 2005
Last Updated: July 24, 2007
ClinicalTrials.gov Identifier: NCT00205504  
Health Authority: United States: Institutional Review Board

Keywords provided by Virginia Commonwealth University:
Inflammatory markers

Study placed in the following topic categories:
Obesity
Metabolic Syndrome X
Metabolic Diseases
Overweight
Body Weight
Hyperinsulinism
Signs and Symptoms
Moxifloxacin
Syndrome X
Nutrition Disorders
Overnutrition
Insulin Resistance
Metabolic disorder
Glucose Metabolism Disorders
Abdominal obesity metabolic syndrome

Additional relevant MeSH terms:
Anti-Infective Agents
Pathologic Processes
Disease
Therapeutic Uses
Syndrome
Cardiovascular Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009