Ignite Creation Date:
2025-12-24 @ 3:21 PM
Ignite Modification Date:
2026-03-06 @ 1:48 PM
Study NCT ID:
NCT02721992
Status:
COMPLETED
Last Update Posted:
2017-08-14
First Post:
2016-03-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Graves' Orbitopathy and Hypercholesterolemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D049970', 'term': 'Graves Ophthalmopathy'}, {'id': 'D006937', 'term': 'Hypercholesterolemia'}], 'ancestors': [{'id': 'D015785', 'term': 'Eye Diseases, Hereditary'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D006111', 'term': 'Graves Disease'}, {'id': 'D005094', 'term': 'Exophthalmos'}, {'id': 'D009916', 'term': 'Orbital Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006042', 'term': 'Goiter'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006980', 'term': 'Hyperthyroidism'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 250}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-10', 'studyFirstSubmitDate': '2016-03-17', 'studyFirstSubmitQcDate': '2016-03-22', 'lastUpdatePostDateStruct': {'date': '2017-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Relationship between LDL cholesterol levels and Graves' Orbitopathy", 'timeFrame': 'Baseline', 'description': "Relationship between the levels of LDL cholesterol and the presence of Graves' Orbitopathy"}], 'secondaryOutcomes': [{'measure': "Relationship between LDL cholesterol levels and the activity of Graves' Orbitopathy", 'timeFrame': 'Baseline', 'description': "Relationship between the levels of LDL cholesterol and the Graves' Orbitopathy clinical activity score"}, {'measure': "Relationship between LDL cholesterol levels and the severity of Graves' Orbitopathy", 'timeFrame': 'Baseline', 'description': "Relationship between the levels of LDL cholesterol the Graves' Orbitopathy severity score (NOSPECS score)"}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ["Graves' Ophthalmopathy", 'Hypercholesterolemia']}, 'descriptionModule': {'briefSummary': "The investigators have recently observed retrospectively that the occurrence of Graves' Orbitopathy in patients with Graves' disease is less frequent in patients with normal cholesterol levels, in line with another recent observation suggesting that statins play a protective role in Graves' patients from developing Graves' Orbitopathy. The present study is designed in order to investigate the possible association between Graves' Orbitopathy and high cholesterol level as well as the relation between Graves' Orbitopathy degree and high cholesterol level"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "Consecutive patients with Graves' disease, with or without Graves' Orbitopathy, off methimazole since two days to perform radioiodine treatment", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Graves' disease with Graves' Orbitopathy\n2. Graves' disease without Graves' Orbitopathy\n\nExclusion Criteria:\n\n1. Previous treatment with radioiodine\n2. Previous treatment with thyroidectomy"}, 'identificationModule': {'nctId': 'NCT02721992', 'acronym': 'GOCol', 'briefTitle': "Graves' Orbitopathy and Hypercholesterolemia", 'organization': {'class': 'OTHER', 'fullName': 'University of Pisa'}, 'officialTitle': "A Prospective Study on the Association Between Graves' Orbitopathy and Hypercholesterolemia", 'orgStudyIdInfo': {'id': 'GOCol'}}, 'armsInterventionsModule': {'armGroups': [{'label': "Graves' Disease", 'description': "Patients with Graves' disease, without Graves' Orbitopathy", 'interventionNames': ['Other: No intervention']}, {'label': "Graves' Orbitopathy", 'description': "Patients with Graves' disease, with Graves' Orbitopathy", 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'No intervention', 'armGroupLabels': ["Graves' Disease", "Graves' Orbitopathy"]}]}, 'contactsLocationsModule': {'locations': [{'zip': '56124', 'city': 'Pisa', 'country': 'Italy', 'facility': 'Ospedale Cisanello-Endocrinology I and II', 'geoPoint': {'lat': 43.70853, 'lon': 10.4036}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pisa', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ricercatore (Assistant Professor)', 'investigatorFullName': 'Marinò Michele', 'investigatorAffiliation': 'University of Pisa'}}}}