This trial is active, not recruiting.

Condition metabolic syndrome
Sponsor University of Washington
Start date May 2009
End date July 2012
Trial size 43 participants
Trial identifier NCT01068535, 35352-A


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
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 pre-menopausal women age 35-50 Body Mass Index ≤ 25 Regular menstrual cycles (occur every 24-35 days) Fasting glucose < 100mg/dL HDL-C ≥ 50mg/dL Waist measurement ≤ 35 inches Fasting triglycerides < 150mg/dL

Primary Outcomes

ktrans of the carotid artery wall
time frame: baseline

Secondary Outcomes

carotid artery intima-media thickness as measured by MRI
time frame: baseline

Eligibility Criteria

Female participants from 35 years up to 50 years old.

Inclusion Criteria: - Pre-menopausal women (age 35-50) - still having menstrual periods 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: - 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

Additional Information

Official title Early Vascular Wall Changes by MRI in Metabolic Syndrome vs. Metabolically Normal Pre-Menopausal Women: A Pilot Study
Principal investigator Pathmaja Paramsothy, M.D.,M.S.
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2012.
Information provided to ClinicalTrials.gov by University of Washington.