Ignite Creation Date:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2026-04-20 @ 3:41 PM
Study NCT ID:
NCT00579228
Status:
COMPLETED
Last Update Posted:
2023-09-14
First Post:
2007-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vascular Risk Progression in Normal and Diabetic Control Subjects.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-04-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2018-03-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-12', 'studyFirstSubmitDate': '2007-12-19', 'studyFirstSubmitQcDate': '2007-12-21', 'lastUpdatePostDateStruct': {'date': '2023-09-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-12-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-03-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Carotid intima media measurement change', 'timeFrame': '2 years', 'description': 'To describe carotid intima media measurement change over 2 year period in normal individuals compared to individuals with well controlled diabetes'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diabetes', 'Vascular risk', 'Inflammation'], 'conditions': ['Diabetes', 'Inflammation']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to look at the progression of cardiovascular disease (CVD) in normal control individuals and in patients with controlled diabetes.', 'detailedDescription': 'Cardiovascular disease remains the greatest cause of mortality in people with diabetes mellitus. This observation study will evaluate non-traditional risk factors for their contributions to vascular disease progression as determined by carotid intima media thickness and history of vascular disease events over 1 year. This study requires annual checks of blood, urine, history, and carotid ultrasound for carotid intimal medical thickness.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Any patient with diabetes or healthy individuals', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 19 years old or more and willing to return for annual testing for 2 years.\n* Those with Diabetes need to have the condition for at least 5 years.\n* Normal controls need to have no diabetes, kidney disease, or chronic disease.\n\nExclusion Criteria:\n\n* Estimated GFR \\<60 (mL/min/1.73m2)\n* Any condition that would change weight dramatically in the near future such as malabsorption, pregnancy, malignancy\n* For Normal: BMI\\>30, BP \\> 140/90 , LDL \\> 130.\n* For Diabetes: BP\\> 135/85, A1C\\> 8%. LDL \\> 100.'}, 'identificationModule': {'nctId': 'NCT00579228', 'briefTitle': 'Vascular Risk Progression in Normal and Diabetic Control Subjects.', 'organization': {'class': 'OTHER', 'fullName': 'University of Nebraska'}, 'officialTitle': 'Vascular Risk Progression in Normal and Diabetes Control Subjects', 'orgStudyIdInfo': {'id': '0124-07-EP'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1 Cardiovascular disease (CVD) in Participants without diabetes', 'description': 'Progression of cardiovascular disease (CVD) in participants without diabetes'}, {'label': '2 Cardiovascular disease (CVD) in participants with type 2 Diabetes', 'description': 'Progression of cardiovascular disease (CVD) in participants with type 2 Diabetes with good control'}, {'label': '3 Cardiovascular disease (CVD) in participants with type 1 diabetes', 'description': 'Progression of cardiovascular disease (CVD) in participants with type 1 diabetes with good control'}]}, 'contactsLocationsModule': {'locations': [{'zip': '68198', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'University of Nebraska Medical Center', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}], 'overallOfficials': [{'name': 'Jennifer Larsen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Nebraska'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Nebraska', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}