Early Vascular Wall Changes by Magnetic Resonance Imaging (MRI) in Metabolic Syndrome Versus Metabolically Normal Pre-Menopausal Women: A Pilot Study
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Early Vascular Wall Changes by MRI in Metabolic Syndrome vs. Metabolically Normal Pre-Menopausal Women: A Pilot Study|
- ktrans of the carotid artery wall [ Time Frame: baseline ] [ Designated as safety issue: No ]Ktrans is a transfer constant that is a measure of vascular permeability.
- carotid artery intima-media thickness as measured by MRI [ Time Frame: baseline ] [ Designated as safety issue: No ]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
|Study Start Date:||May 2009|
|Estimated Study Completion Date:||July 2013|
|Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01068535
|United States, Washington|
|Harborview/University of Washington|
|Seattle, Washington, United States, 98104|
|Principal Investigator:||Pathmaja Paramsothy, M.D.,M.S.||University of Washington|