Ignite Creation Date:
2025-12-25 @ 12:54 AM
Ignite Modification Date:
2026-02-21 @ 4:08 AM
Study NCT ID:
NCT01781767
Status:
UNKNOWN
Last Update Posted:
2013-02-01
First Post:
2013-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Changes in Metabolic Status in Patients With Total Thyroidectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013964', 'term': 'Thyroid Neoplasms'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Whole blood for UCP2 mRNA'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2014-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-01-30', 'studyFirstSubmitDate': '2013-01-27', 'studyFirstSubmitQcDate': '2013-01-30', 'lastUpdatePostDateStruct': {'date': '2013-02-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-02-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in UCP2 mRNA concentrations.', 'timeFrame': 'Base line (before opporation), 2 weeks after opporation and for after opporation.', 'description': 'The difference between the result at two weeks and four months compare to base line.'}], 'secondaryOutcomes': [{'measure': 'Weight', 'timeFrame': 'Approximately 4 months'}, {'measure': 'Resting energy expenditure', 'timeFrame': 'Approximatly 4 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['UCP2', 'Thyroid function', 'Thyroid carcinoma'], 'conditions': ['Thyroid Cancer']}, 'referencesModule': {'references': [{'pmid': '11427693', 'type': 'BACKGROUND', 'citation': 'Yen PM. Physiological and molecular basis of thyroid hormone action. Physiol Rev. 2001 Jul;81(3):1097-142. doi: 10.1152/physrev.2001.81.3.1097.'}, {'pmid': '203955', 'type': 'BACKGROUND', 'citation': 'Schwartz HL, Oppenheimer JH. Physiologic and biochemical actions of thyroid hormone. Pharmacol Ther B. 1978;3(3):349-76. doi: 10.1016/s0306-039x(78)80002-6. No abstract available.'}, {'pmid': '16098826', 'type': 'BACKGROUND', 'citation': 'Brand MD, Esteves TC. Physiological functions of the mitochondrial uncoupling proteins UCP2 and UCP3. Cell Metab. 2005 Aug;2(2):85-93. doi: 10.1016/j.cmet.2005.06.002.'}, {'pmid': '6320232', 'type': 'BACKGROUND', 'citation': 'Nicholls DG, Locke RM. Thermogenic mechanisms in brown fat. Physiol Rev. 1984 Jan;64(1):1-64. doi: 10.1152/physrev.1984.64.1.1. No abstract available.'}, {'pmid': '20427509', 'type': 'BACKGROUND', 'citation': 'Gjedde S, Gormsen LC, Riis AL, Jorgensen JO, Rungby J, Moller N, Weeke J, Pedersen SB. Reduced expression of uncoupling protein 2 in adipose tissue in patients with hypothyroidism. J Clin Endocrinol Metab. 2010 Jul;95(7):3537-41. doi: 10.1210/jc.2009-0907. Epub 2010 Apr 28.'}]}, 'descriptionModule': {'briefSummary': 'This study objective is to evaluate the change in mitochondrial uncoupling protein 2 (UCP2) mRNA expression as function of thyroid activity (TSH, T3 and Free T4).', 'detailedDescription': 'Blood will be drown before thyroidectomy, 2 weeks after the operation and 3-4 month after the operation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who were diagnosed with thyroid carcinoma and are going throgh total thyroidectomy and recive a thyroid replacement therapy.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who were diagnosed with thyroid carcinoma and are going to have total thyroidectomy.\n* Patients with unbalanced thyroid hormones.\n* Aged 18-65 years at the time of screening.\n* Provision of written informed consent.\n\nExclusion Criteria:\n\n* Patients with Diabetes.\n* Patients with any other chronic inflammatory diseases.\n* Steroid treatment.'}, 'identificationModule': {'nctId': 'NCT01781767', 'acronym': 'Thyroid cancer', 'briefTitle': 'Changes in Metabolic Status in Patients With Total Thyroidectomy', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Tel-Aviv Sourasky Medical Center'}, 'orgStudyIdInfo': {'id': 'TASMC-12-NV-376-CTIL'}}, 'contactsLocationsModule': {'locations': [{'zip': '64239', 'city': 'Tel Aviv', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Nachum Vaisman, M.D.', 'role': 'CONTACT', 'email': 'vaisman@tasmc.health.gov.il', 'phone': '972-3-6974807'}], 'facility': 'Tel Aviv Sourasky Medical Center', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}], 'centralContacts': [{'name': 'Nachum Vaisman, M.D.', 'role': 'CONTACT', 'email': 'vaisman@tasmc.health.gov.il', 'phone': '972-3-6974807'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tel-Aviv Sourasky Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}