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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01068535
Recruitment Status : Unknown
Verified September 2012 by University of Washington.
Recruitment status was:  Active, not recruiting
First Posted : February 15, 2010
Last Update Posted : September 14, 2012
Information provided by (Responsible Party):
University of Washington

Brief Summary:
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.

Condition or disease
Metabolic Syndrome

Detailed 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.

Study Type : Observational
Actual Enrollment : 43 participants
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
Study Start Date : May 2009
Actual Primary Completion Date : July 2012
Estimated Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

  • 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 Outcome Measures :
  1. ktrans of the carotid artery wall [ Time Frame: baseline ]
    Ktrans is a transfer constant that is a measure of vascular permeability.

Secondary Outcome Measures :
  1. carotid artery intima-media thickness as measured by MRI [ Time Frame: baseline ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Pre-menopausal Women

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01068535

United States, Washington
Harborview/University of Washington
Seattle, Washington, United States, 98104
Sponsors and Collaborators
University of Washington
Principal Investigator: Pathmaja Paramsothy, M.D.,M.S. University of Washington

Responsible Party: University of Washington Identifier: NCT01068535     History of Changes
Other Study ID Numbers: 35352-A
First Posted: February 15, 2010    Key Record Dates
Last Update Posted: September 14, 2012
Last Verified: September 2012

Keywords provided by University of Washington:
metabolic syndrome
premenopausal women
vascular risk
atherosclerosis detection

Additional relevant MeSH terms:
Metabolic Syndrome X
Pathologic Processes
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases