- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01068535
Early Vascular Wall Changes by Magnetic Resonance Imaging (MRI) in Metabolic Syndrome Versus Metabolically Normal Pre-Menopausal Women: A Pilot Study
Early Vascular Wall Changes by MRI in Metabolic Syndrome vs. Metabolically Normal Pre-Menopausal Women: A Pilot Study
Study Overview
Status
Conditions
Detailed Description
This study involves a phone screen & 2 study visits:
- Screening visit, which includes a quick finger stick cholesterol, glucose, triglycerides test (cholestech) to determine qualification, waist measurement, weight. Results are provided regardless of qualification. If the volunteer qualifies, a full blood draw (approximately 45cc or 3 Tablespoons) will occur. A snack is provided once blood is drawn. Additional study visit procedures include a medical history questionnaire including menstrual history, height & weight measurement, vital signs, and waist & hip measurements. This study lasts up to 90 minutes.
- MRI visit (to occur within a week of screening visit) occurs once serum pregnancy & creatinine results are received & only if approved to continue by P.I. (e.g. negative serum pregnancy and eGFR>60). An IV catheter is placed in the antecubital vein to administer an injection of (gadolinium) contrast medium. A coil is placed on each side of the subject's neck while laying flat on a bench, with her upper body inside the MRI scanner. The entire MRI procedure takes approximately 60 minutes.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Washington
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Seattle, Washington, United States, 98104
- Harborview/University of Washington
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
Pre-menopausal women (age 35-50)
- still having menstrual periods
Exclusion Criteria:
- History of diabetes mellitus
- History of cardiovascular disease (peripheral vascular disease, coronary artery disease, cerebrovascular disease)
- Serum creatinine >1.2 mg/dL (eGFR <60 ml/min.)
- Active rheumatologic disease
- Use of hormonal contraception*
- Pregnant or planning a pregnancy within the next 3 months
- Fasting triglycerides ≥ 500 mg/dL
- Fasting LDL-C ≥ 190 mg/dL
- Currently taking lipid lowering medications*
- Currently taking vaso-active (blood pressure) medications*
- Hypertension: SBP ≥ 140 and or DBP ≥90 mm Hg
- Chronic use of aspirin (prn use is allowed)
- Chronic use of non-steroidal anti-inflammatory medications (prn use is allowed)
- Tobacco use within 3 months of starting study
- Participation in another clinical trial within the last 30 days
MRI specific exclusion criteria:
- History of claustrophobia
- History of decrease in kidney function (eGFR <60 ml/min.)
- History of reaction to a contrast medium or dye used for an MRI, CT Scan, or X-ray
- History of significant anemia or other blood disease
- History of seizures
- MRI-incompatible metal such as internal metal hardware or devices * Drugs within the following classifications are exclusionary: Antilipemics, antilipidemics, beta blockers, ACE inhibitors, angiotensin receptor blockers, diuretics, calcium channel blockers, alpha blockers, nitrates, and all hormonal contraceptives
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Women with Metabolic Syndrome
Pre-menopausal women with Metabolic Syndrome Age 35-50 and any 3 of the following: Fasting triglycerides ≥ 150 mg/dL, Waist measurement ≥ 35 inches, HDL < 50mg/dL, Fasting glucose ≥ 100mg/dL but <126mg/dL or Blood pressure ≥ 130/85 or taking medication to treat high blood pressure. |
Non-Metabolic Syndrome (healthy) women
Non-Metabolic syndrome pre-menopausal women age 35-50
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ktrans of the carotid artery wall
Time Frame: baseline
|
Ktrans is a transfer constant that is a measure of vascular permeability.
|
baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
carotid artery intima-media thickness as measured by MRI
Time Frame: baseline
|
Carotid intima-media thickness is a measure of the actual thickness of the intima and media layers of the carotid artery wall.
|
baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Pathmaja Paramsothy, M.D.,M.S., University of Washington
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 35352-A
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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