Early Vascular Wall Changes by Magnetic Resonance Imaging (MRI) in Metabolic Syndrome Versus Metabolically Normal Pre-Menopausal Women: A Pilot Study
Recruitment status was Active, not recruiting
The purpose of this study is to compare the vascular permeability of blood vessel walls (of the carotid artery) in pre-menopausal women who have metabolic syndrome (syndrome of having at least 3/5 following features- increased abdominal fat, low good cholesterol (HDL-C), elevated fasting blood fats (triglycerides), elevated blood pressure, an elevated fasting glucose) versus those women who are normal weight and with normal cholesterol, blood fats, blood pressure, and blood sugar. We are using a novel technology to measure vascular permeability known as dynamic contrast enhancement magnetic resonance imaging (DCE-MRI). The primary variable is ktrans ratio which is a mathematically derived quantity obtained from DCE-MRI. We are trying to identify novel markers of early atherosclerosis in young women.
|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
Lipids, LDL-Buoyancy, Apo-B, Apo-A1 Inflammatory markers: hs-CRP, SAA, IL-6, & TNF-α Vascular Adhesion Markers: VCAM, sICAM
|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|