Metabolic Syndrome XPhase 4NCT00205504

Oral Contraceptives in the Metabolic Syndrome

A Phase 4 study testing Ortho Tri Cyclen in people with Metabolic Syndrome X and Insulin Resistance, run by Virginia Commonwealth University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 40 years, women onlyHealthy volunteers can take part
Conditions the study is for: Metabolic Syndrome X, Insulin Resistance, Obesity
What is being tested?: Ortho Tri Cyclen
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 46 participants
Where: 1 siteUnited States
Study dates: Jun 2005to Jun 2009
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 40 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

Acceptable health based on interview, medical history, physical examination, and laboratory tests (comprehensive metabolic panel - SMA20, and complete blood count - CBC);
Have not taken oral contraceptives (OCs) in the past 3 months;
Ability to comply with the requirements of the study;
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:
increased waist circumference > 35 inches,
hypertriglyceridemia ≥ 150 mg/dL,

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low high-density lipoprotein (HDL) cholesterol < 50 mg/dL in women,
hypertension (≥ 130/≥ 85 mmHg),
fasting glucose ≥ 100 mg/dL.
Obese women with or without the metabolic syndrome should have a Body Mass Index (BMI) > 30 kg/m2 and lean women should have a Body Mass Index BMI < 25 kg/m2.

Who cannot join

Diabetes mellitus by fasting glucose or a 2-hour oral glucose tolerance test (OGTT);
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);
History of thromboembolism, myocardial infarction, cerebrovascular accident, vascular disease, known coagulopathy, prolonged immobilization, or recent major surgery (within past 6 months);
Systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than 100 mmHg (mild hypertension is not an exclusion criterion);
History of breast cancer, migraine headaches, or age ≥ 35 years and smoker of ≥ 20 cigarettes/day;
Use of metformin, thiazolidinediones, anti-hyperlipidemic drugs, anti-hypertensive drugs, glucocorticoids, or anti-androgens (spironolactone, flutamide, etc.) within 3 months;

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Documented or suspected illicit drug abuse or alcoholism within one year;
Ingestion of any investigational drugs within 3 months prior to the study onset; and
Pregnancy or lactation (≤ 6 weeks postpartum);
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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Virginia Commonwealth University General Clinical Research Center
Richmond, Virginia, 23298

Other trials in United States

About this study

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 (such as obesity and the metabolic syndrome) have not been investigated. 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 and obesity affects glucose metabolism and cardiovascular risks in women taking OCs. The researchers hypothesize that women with metabolic syndrome and obese women will have worsened glucose metabolism and elevated cardiovascular risks associated with OC use, when compared to normal weight women without the metabolic syndrome. 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.

Conditions: Metabolic Syndrome X, Insulin Resistance, Obesity, Cardiovascular Diseases
Being tested: Ortho Tri Cyclen
Keywords: Inflammatory markers, oral contraceptions, obesity, metabolic syndrome X
Medical subject headings: Metabolic Syndrome, Insulin Resistance, Obesity, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ortho Tri CyclenDrug
Ortho Tri Cyclen, one tablet daily, for 6 cycles

Study groups in NCT00205504
Study group	Role	What they receive
Obese women with metabolic syndrome	Active comparator	Not described Receives: Drug: Ortho Tri Cyclen
Obese women without metabolic syndrome	Active comparator	Not described Receives: Drug: Ortho Tri Cyclen
lean women without metabolic syndrome	Active comparator	Not described Receives: Drug: Ortho Tri Cyclen

What is being measured

The primary outcome is the main question the study is designed to answer.

Changes in Insulin Sensitivity Associated With Oral Contraceptive (OC) Use Compared Among (1) Obese Women and (2) Lean Women
Insulin sensitivity was assessed by frequent sampling intravenous glucose tolerance test (FSIVGTT).
Measured: Baseline and 6 months

Secondary outcomes (9)

Changes in Lipid Profile Compared Associated With OC Use Among (1) Obese Women and (2) Lean Women
The lipid profile is assessed through blood sample analysis for low-density lipoprotein (LDL), Triglycerides and high-density lipoprotein (HDL).
Measured: Baseline and 6 months
Inflammatory Marker Changes, High Sensitive C-reactive Protein (Hs-CRP) and Adiponectin, Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women
Inflammatory markers are assessed through blood analysis for C-reactive protein (hs-CRP) and adiponectin.
Measured: Baseline and 6 months
Changes in Estrogen Metabolites (Plasma) Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women
Measured: Baseline and 6 months
Changes in Waist-to-Hip Ratio Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women
Waist-to-hip ratio is assessed through calculated ratio of waist and hip circumference.
Measured: Baseline and 6 months
Inflammatory Marker Changes (MCP-1) Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women
Inflammatory marker is assessed through blood analysis for Monocyte chemotactic protein-1 (MCP-1).
Measured: Baseline and 6 months
Changes in Blood Pressure Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women
Measured: Baseline and 6 months
Changes in Body Mass Index (BMI) Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women
Body Mass Index is a calculation of height and weight: kg/m²
Measured: Baseline and 6 months
Changes in Waist Circumference Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women
Measured: Baseline and 6 months
Inflammatory Marker Changes, Soluble Vascular Cell Adhesion Molecule (sVCAM) and Soluble Intercellular Adhesion Molecule (sICAM), Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women
These inflammatory markers are assessed through blood analysis of Soluble Vascular Cell Adhesion Molecule (sVCAM) and soluble intercellular adhesion molecule (sICAM).
Measured: Baseline and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2005Jun 2009

First posted20 Sep 2005 (estimated)
Study startJun 2005
Primary completionJun 2009
Study completionJun 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Metabolic Syndrome XStudies of the same condition, open and under way.
More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 46 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00205504
Sponsor's protocol ID: HM4060
Status last verified: Jul 2018
First submitted: 13 Sep 2005
Last updated: 8 Aug 2018
Results posted: Yes, on ClinicalTrials.gov

Publications

Cheang KI, Essah PA, Sharma S, Wickham EP 3rd, Nestler JE. Divergent effects of a combined hormonal oral contraceptive on insulin sensitivity in lean versus obese women. Fertil Steril. 2011 Aug;96(2):353-359.e1. doi: 10.1016/j.fertnstert.2011.05.039. Epub 2011 Jun 15.
PubMed 21676394

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Metabolic Syndrome X trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Oral Contraceptives in the Metabolic Syndrome
ClinicalTrials.gov ID: NCT00205504
Acronym / sponsor ID: HM4060
Conditions: Metabolic Syndrome X, Insulin Resistance, Obesity, Cardiovascular Diseases
Keywords: Inflammatory markers, oral contraceptions, obesity, metabolic syndrome X
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 46 participants (actual)
Lead sponsor: Virginia Commonwealth UniversityUniversity, hospital or other
Study start: Jun 2005
Primary completion: Jun 2009 (actual)
Study completion: Jun 2009 (actual)
First posted: 20 Sep 2005 (estimated)
Results: Posted 7 May 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Obese women with metabolic syndrome	Active comparator	Drug: Ortho Tri Cyclen
Obese women without metabolic syndrome	Active comparator	Drug: Ortho Tri Cyclen
lean women without metabolic syndrome	Active comparator	Drug: Ortho Tri Cyclen

Who may qualify

Ages: 18 to 40 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (10 listed)

Acceptable health based on interview, medical history, physical examination, and laboratory tests (comprehensive metabolic panel - SMA20, and complete blood count - CBC);
Have not taken oral contraceptives (OCs) in the past 3 months;
Ability to comply with the requirements of the study;
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:
Obese women with or without the metabolic syndrome should have a Body Mass Index (BMI) > 30 kg/m2 and lean women should have a Body Mass Index BMI < 25 kg/m2.

Key exclusion criteria (10 listed)

Diabetes mellitus by fasting glucose or a 2-hour oral glucose tolerance test (OGTT);
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);
History of thromboembolism, myocardial infarction, cerebrovascular accident, vascular disease, known coagulopathy, prolonged immobilization, or recent major surgery (within past 6 months);
Systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than 100 mmHg (mild hypertension is not an exclusion criterion);
History of breast cancer, migraine headaches, or age ≥ 35 years and smoker of ≥ 20 cigarettes/day;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Ortho Tri CyclenOrtho Tri Cyclen, one tablet daily, for 6 cycles	Drug	Obese women with metabolic syndrome, Obese women without metabolic syndrome, lean women without metabolic syndrome

Primary outcome

Changes in Insulin Sensitivity Associated With Oral Contraceptive (OC) Use Compared Among (1) Obese Women and (2) Lean Women
Time frame: Baseline and 6 months
Insulin sensitivity was assessed by frequent sampling intravenous glucose tolerance test (FSIVGTT).

9 secondary outcomes

Changes in Lipid Profile Compared Associated With OC Use Among (1) Obese Women and (2) Lean Women
Time frame: Baseline and 6 months
Inflammatory Marker Changes, High Sensitive C-reactive Protein (Hs-CRP) and Adiponectin, Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women
Time frame: Baseline and 6 months
Changes in Estrogen Metabolites (Plasma) Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women
Time frame: Baseline and 6 months
Changes in Waist-to-Hip Ratio Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women
Time frame: Baseline and 6 months
Inflammatory Marker Changes (MCP-1) Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women
Time frame: Baseline and 6 months
Changes in Blood Pressure Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women
Time frame: Baseline and 6 months
Changes in Body Mass Index (BMI) Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women
Time frame: Baseline and 6 months
Changes in Waist Circumference Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women
Time frame: Baseline and 6 months
Inflammatory Marker Changes, Soluble Vascular Cell Adhesion Molecule (sVCAM) and Soluble Intercellular Adhesion Molecule (sICAM), Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women
Time frame: Baseline and 6 months

Results and safety

Results posted to the registry on 7 May 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Obese Women	21	14
Lean Women	15	15

Primary outcome: Changes in Insulin Sensitivity Associated With Oral Contraceptive (OC) Use Compared Among (1) Obese Women and (2) Lean Women

Time frame: Baseline and 6 months. Mean (Standard Deviation). Unit: mIU/L

Measure	Obese Women n = 14	Lean Women n = 15
Baseline Insulin sensitivity	4.36 (2.32)	6.62 (3.69)
6 months Insulin sensitivity	3.82 (3.12)	8.23 (3.30)

9 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Obese Women	1 of 21 (4.8%)	2 of 21 (9.5%)	Not reported
Lean Women	0 of 15 (0%)	2 of 15 (13.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 21676394Cheang KI, Essah PA, Sharma S, Wickham EP 3rd, Nestler JE. Divergent effects of a combined hormonal oral contraceptive on insulin sensitivity in lean versus obese women. Fertil Steril. 2011 Aug;96(2):353-359.e1. doi: 10.1016/j.fertnstert.2011.05.039. Epub 2011 Jun 15.

Related trials for Metabolic Syndrome X

Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
RecruitingObservational study
Longitudinal Study of Ultra-rare Inherited Metabolic and Degenerative Neurological Diseases.
Inherited Disease, Rare Diseases
RecruitingObservational study
Cancer in Inherited Bone Marrow Failure Syndromes
Diamond Blackfan Anemia, Dyskeratosis Congenita
RecruitingPhase 1/2
The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function
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Enrolling by invitationEarly Phase 1
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kai I Cheang, Pharm.D. principal investigator

Virginia Commonwealth University

John E Nestler, M.D. study director

Virginia Commonwealth University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ortho Tri Cyclen in people with Metabolic Syndrome X and Insulin Resistance, run by Virginia Commonwealth University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 May 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in Insulin Sensitivity Associated With Oral Contraceptive (OC) Use Compared Among (1) Obese Women and (2) Lean Women (time frame: Baseline and 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00205504, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2018.