Early Vascular Wall Changes by Magnetic Resonance Imaging (MRI) in Metabolic Syndrome Versus Metabolically Normal Pre-Menopausal Women: A Pilot Study

Status unconfirmed

Conditions studied: Metabolic Syndrome

In brief

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.

Key facts

Study ID

NCT01068535

Run by

University of Washington

People needed

43

Starts

2009-05-01

Expected to finish

2013-07-01

Last updated by the study team

2012-09-14

Who can join

Age: 35 and older, up to 50. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Pre-menopausal women (age 35-50)
• still having menstrual periods

You may not qualify if…

• 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

Where it is running

• Harborview/University of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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