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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Washington
ClinicalTrials.gov Identifier:
NCT01068535
First received: February 11, 2010
Last updated: September 12, 2012
Last verified: September 2012
History of Changes
  Purpose

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
Metabolic Syndrome

Study Type: Observational
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Washington:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 43
Study Start Date: May 2009
Estimated Study Completion Date: July 2013
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.
  Eligibility

Ages Eligible for Study:   35 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Pre-menopausal Women

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01068535

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

No publications provided

Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT01068535     History of Changes
Other Study ID Numbers: 35352-A
Study First Received: February 11, 2010
Last Updated: September 12, 2012
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on June 18, 2013