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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.
This study involves a phone screen & 2 study visits:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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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| Measure | Description | Time Frame |
|---|---|---|
| ktrans of the carotid artery wall | Ktrans is a transfer constant that is a measure of vascular permeability. | baseline |
| Measure | Description | Time Frame |
|---|---|---|
| carotid artery intima-media thickness as measured by MRI | Carotid intima-media thickness is a measure of the actual thickness of the intima and media layers of the carotid artery wall. | baseline |
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Inclusion Criteria:
Pre-menopausal women (age 35-50)
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:
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Pre-menopausal Women
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| Name | Affiliation | Role |
|---|---|---|
| Pathmaja Paramsothy, M.D.,M.S. | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harborview/University of Washington | Seattle | Washington | 98104 | United States |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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Lipids, LDL-Buoyancy, Apo-B, Apo-A1 Inflammatory markers: hs-CRP, SAA, IL-6, & TNF-α Vascular Adhesion Markers: VCAM, sICAM
| D009750 |
| Nutritional and Metabolic Diseases |