Ignite Creation Date:
2025-12-24 @ 10:36 PM
Ignite Modification Date:
2025-12-29 @ 9:51 AM
Study NCT ID:
NCT01068535
Status:
UNKNOWN
Last Update Posted:
2012-09-14
First Post:
2010-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Vascular Wall Changes by Magnetic Resonance Imaging (MRI) in Metabolic Syndrome Versus Metabolically Normal Pre-Menopausal Women: A Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024821', 'term': 'Metabolic Syndrome'}], 'ancestors': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Lipids, LDL-Buoyancy, Apo-B, Apo-A1 Inflammatory markers: hs-CRP, SAA, IL-6, \\& TNF-α Vascular Adhesion Markers: VCAM, sICAM'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2013-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-09-12', 'studyFirstSubmitDate': '2010-02-11', 'studyFirstSubmitQcDate': '2010-02-12', 'lastUpdatePostDateStruct': {'date': '2012-09-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ktrans of the carotid artery wall', 'timeFrame': 'baseline', 'description': 'Ktrans is a transfer constant that is a measure of vascular permeability.'}], 'secondaryOutcomes': [{'measure': 'carotid artery intima-media thickness as measured by MRI', 'timeFrame': 'baseline', 'description': 'Carotid intima-media thickness is a measure of the actual thickness of the intima and media layers of the carotid artery wall.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['metabolic syndrome', 'MetS', 'premenopausal women', 'vascular risk', 'atherosclerosis detection'], 'conditions': ['Metabolic Syndrome']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "This study involves a phone screen \\& 2 study visits:\n\n* 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.\n* 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."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '35 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pre-menopausal Women', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pre-menopausal women (age 35-50)\n\n * still having menstrual periods\n\nExclusion Criteria:\n\n* History of diabetes mellitus\n* History of cardiovascular disease (peripheral vascular disease, coronary artery disease, cerebrovascular disease)\n* Serum creatinine \\>1.2 mg/dL (eGFR \\<60 ml/min.)\n* Active rheumatologic disease\n* Use of hormonal contraception\\*\n* Pregnant or planning a pregnancy within the next 3 months\n* Fasting triglycerides ≥ 500 mg/dL\n* Fasting LDL-C ≥ 190 mg/dL\n* Currently taking lipid lowering medications\\*\n* Currently taking vaso-active (blood pressure) medications\\*\n* Hypertension: SBP ≥ 140 and or DBP ≥90 mm Hg\n* Chronic use of aspirin (prn use is allowed)\n* Chronic use of non-steroidal anti-inflammatory medications (prn use is allowed)\n* Tobacco use within 3 months of starting study\n* Participation in another clinical trial within the last 30 days\n* MRI specific exclusion criteria:\n\n * History of claustrophobia\n * History of decrease in kidney function (eGFR \\<60 ml/min.)\n * History of reaction to a contrast medium or dye used for an MRI, CT Scan, or X-ray\n * History of significant anemia or other blood disease\n * History of seizures\n * 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'}, 'identificationModule': {'nctId': 'NCT01068535', 'briefTitle': 'Early Vascular Wall Changes by Magnetic Resonance Imaging (MRI) in Metabolic Syndrome Versus Metabolically Normal Pre-Menopausal Women: A Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'Early Vascular Wall Changes by MRI in Metabolic Syndrome vs. Metabolically Normal Pre-Menopausal Women: A Pilot Study', 'orgStudyIdInfo': {'id': '35352-A'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Women with Metabolic Syndrome', 'description': 'Pre-menopausal women with Metabolic Syndrome\n\nAge 35-50 and any 3 of the following:\n\nFasting 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.'}, {'label': 'Non-Metabolic Syndrome (healthy) women', 'description': 'Non-Metabolic syndrome pre-menopausal women age 35-50\n\n* Body Mass Index ≤ 25\n* Regular menstrual cycles (occur every 24-35 days)\n* Fasting glucose \\< 100mg/dL\n* HDL-C ≥ 50mg/dL\n* Waist measurement ≤ 35 inches\n* Fasting triglycerides \\< 150mg/dL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Harborview/University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Pathmaja Paramsothy, M.D.,M.S.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}