Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2026-02-24 @ 4:11 AM
Study NCT ID:
NCT01831869
Status:
UNKNOWN
Last Update Posted:
2018-09-12
First Post:
2013-04-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of L-Thyroxine on Lipid Profiles and Atherosclerosis in Subclinical Hypothyroidism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007037', 'term': 'Hypothyroidism'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013974', 'term': 'Thyroxine'}], 'ancestors': [{'id': 'D013963', 'term': 'Thyroid Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D024322', 'term': 'Amino Acids, Aromatic'}, {'id': 'D000598', 'term': 'Amino Acids, Cyclic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2022-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-09-11', 'studyFirstSubmitDate': '2013-04-07', 'studyFirstSubmitQcDate': '2013-04-10', 'lastUpdatePostDateStruct': {'date': '2018-09-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-04-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in lipid profile', 'timeFrame': 'measured at baseline; 6 month; 12 months and 24 months.'}, {'measure': 'change in thickness of blood vessel wall', 'timeFrame': 'measured at baseline; 6 months; 12 months and 24 months.'}], 'secondaryOutcomes': [{'measure': 'change in endothelial function', 'timeFrame': 'measured at baseline; 6 months; 12 months and 24 months.'}, {'measure': 'change of adipocytokines', 'timeFrame': 'measured at baseline; 6 months; 12 months and 24 months.'}, {'measure': 'Change of Oxidative Stress and Chronic Inflammatory Factors Related with Atherosclerosis', 'timeFrame': 'measured at baseline; 6 months; 12 months and 24 months.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Subclinical hypothyroidism', 'L-thyroxine', 'Lipid', 'endothelial function', 'inflammatory factor', 'adipocytokine'], 'conditions': ['Hypothyroidism', 'Thyroid Diseases', 'Endocrine System Diseases']}, 'descriptionModule': {'briefSummary': 'Subclinical hypothyroidism (SCH) is a common condition affecting 3-10% of the general population, especially in women older than 50 years old. It is controversial whether SCH can lead to increased risks of cardiovascular (CV) disease and whether treatment with L-thyroxine reverses these risks. The present study was designed to evaluate the effect of L-thyroxine treatment in SCH on lipid profile, atherosclerosis, endothelial function, serum inflammatory factors and adipocytokines.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female aged of 18 to 60 years old;\n* Diagnosis was subclinical hypothyroidism(elevated serum thyroid-stimulating hormone levels with normal serum free T4 levels measured at least two times with a three-month interval);\n* untreated.\n\nExclusion Criteria:\n\n* Pregnancy or lactation women;\n* Presence of pituitary/hypothalamic disorders, diabetes mellitus or other endocrinal and metabolic disorders;\n* Presence of psychological or physical disabilities,acute infection, cerebrovascular or cardiovascular disease, chronic respiratory disease and other illnesses known to alter lipid metabolism;\n* Taking lipid-lowering agents and other drugs that known to influence thyroid function, blood pressure, heart function or bile acids;\n* Obviously poor compliance.'}, 'identificationModule': {'nctId': 'NCT01831869', 'briefTitle': 'Effect of L-Thyroxine on Lipid Profiles and Atherosclerosis in Subclinical Hypothyroidism', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Shandong Provincial Hospital'}, 'officialTitle': 'The Beneficial Effect of L-Thyroxine Long -Term Replacement on Lipid Profiles and Atherosclerosis in Subclinical Hypothyroidism: A Prospective Study', 'orgStudyIdInfo': {'id': '2012GSF11824'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'L-thyroxine', 'description': 'Oral administration, starting dose 25 or 50 micrograms once daily.', 'interventionNames': ['Drug: L-thyroxine']}, {'type': 'NO_INTERVENTION', 'label': 'blank', 'description': 'no intervention'}], 'interventions': [{'name': 'L-thyroxine', 'type': 'DRUG', 'armGroupLabels': ['L-thyroxine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '250021', 'city': 'Jinan', 'state': 'Shandong', 'country': 'China', 'facility': 'Shandong Provincial Hospital', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}], 'overallOfficials': [{'name': 'Jiajun Zhao', 'role': 'STUDY_CHAIR', 'affiliation': 'Shandong Provincial Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shandong Provincial Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Ling Gao', 'investigatorAffiliation': 'Shandong Provincial Hospital'}}}}