Early Vascular Wall Changes by Magnetic Resonance Imaging (MRI) in Metabolic Syndrome Versus Metabolically Normal Pre-Menopausal Women: A Pilot Study
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|ClinicalTrials.gov Identifier: NCT01068535|
Recruitment Status : Unknown
Verified September 2012 by University of Washington.
Recruitment status was: Active, not recruiting
First Posted : February 15, 2010
Last Update Posted : September 14, 2012
|Condition or disease|
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 :||Observational|
|Actual Enrollment :||43 participants|
|Observational Model:||Case Control|
|Official Title:||Early Vascular Wall Changes by MRI in Metabolic Syndrome vs. Metabolically Normal Pre-Menopausal Women: A Pilot Study|
|Study Start Date :||May 2009|
|Actual Primary Completion Date :||July 2012|
|Estimated Study Completion Date :||July 2013|
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
- ktrans of the carotid artery wall [ Time Frame: baseline ]Ktrans is a transfer constant that is a measure of vascular permeability.
- 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.
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01068535
|United States, Washington|
|Harborview/University of Washington|
|Seattle, Washington, United States, 98104|
|Principal Investigator:||Pathmaja Paramsothy, M.D.,M.S.||University of Washington|