Ignite Creation Date:
2025-12-24 @ 11:07 PM
Ignite Modification Date:
2026-01-04 @ 10:35 AM
Study NCT ID:
NCT01744769
Status:
UNKNOWN
Last Update Posted:
2012-12-07
First Post:
2012-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Thyroid Hormone Withdrawal on Metabolic Parameters During Radioactive Iodine Therapy in Thyroid Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007037', 'term': 'Hypothyroidism'}, {'id': 'D013964', 'term': 'Thyroid Neoplasms'}], 'ancestors': [{'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2013-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-12-06', 'studyFirstSubmitDate': '2012-12-05', 'studyFirstSubmitQcDate': '2012-12-06', 'lastUpdatePostDateStruct': {'date': '2012-12-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-12-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes of metabolic parameters', 'timeFrame': 'Before 1month of radioiodine therapy, Day of radioiodine therapy, After 1 month of radioiodine therapy', 'description': '* glucose profiles : HbA1c, fasting glucose level\n* lipid profiles : free fatty acid, total, LDL-, HDL-, cholesterol, triglyceride\n* adipocytokines : retinol binding protein(RBP)4, leptin, resistin, adiponectin\n* markers of endothelial and cardiac function : high-sensitivity C-reactive - protein(hsCRP), homocystein, B-type natriuretic peptide(BNP)'}], 'secondaryOutcomes': [{'measure': 'Changes of bone turnover markers', 'timeFrame': 'Before 1month of radioiodine therapy, Day of radioiodine therapy, After 1 month of radioiodine terapy', 'description': '* bone formation marker: bone ALP\n* bone resorption marker: CTX'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['thyroid cancer', 'hypothyroidism', 'metabolic parameters', 'Hypothyroidism after levothyroxine withdrawal'], 'conditions': ['Hypothyroidism']}, 'descriptionModule': {'briefSummary': '1. The incidence of differentiated thyroid cancer is increasing in Korea. A significant number of them experience severe hypothyroidism in preparation for radioactive iodine (RAI) therapy after total thyroidectomy.\n2. Because the function of thyroid hormone is closely linked with lipid and glucose metabolism, overt hypothyroidism after thyroid hormone withdrawal during RAI therapy may induce the changes of metabolic parameters.\n3. We investigate the effects of thyroid hormone withdrawal on metabolic and cardiovascular parameters during radioactive iodine therapy in differentiated thyroid cancer.', 'detailedDescription': '1. Study design measurement of various parameters during hypothyroid state (before 1 month, the day and after 1 month of RAI therapy)\n2. Measurements\n\n 1. Measurement of metabolic and cardiovascular parameters\n\n * glucose profiles : HbA1c, fasting glucose level\n * lipid profiles : free fatty acid, total, LDL-, HDL-, cholesterol, triglyceride\n * adipocytokines : retinol binding protein(RBP)\n * 4, leptin, resistin, adiponectin\n * markers of endothelial and cardiac function : high-sensitivity C-reactive protein(hsCRP), homocystein, B-type natriuretic peptide(BNP)\n * bone turnover markers : CTX, bone ALP\n 2. Scoring of symptoms and signs of hypothyroidism (Zulewski score)\n\n * symptoms\n * physical signs'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'the patients who experience severe hypothyroidism after thyroid hormone withdrawal for radioiodine therapy in differentiated thyroid cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* radioiodine therapy after total thyroidectomy in differentiated thyroid cancer\n* age over 18\n\nExclusion Criteria:\n\n* kidney failure, liver failure, heart failure\n* infection\n* inflammation\n* autoimmune disease\n* other chronic disease'}, 'identificationModule': {'nctId': 'NCT01744769', 'briefTitle': 'Effects of Thyroid Hormone Withdrawal on Metabolic Parameters During Radioactive Iodine Therapy in Thyroid Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Konkuk University Medical Center'}, 'officialTitle': 'Effects of Thyroid Hormone Withdrawal on Metabolic and Cardiovascular Parameters During Radioactive Iodine Therapy in Differentiated Thyroid Cancer', 'orgStudyIdInfo': {'id': 'KUH1010379'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Hypothyroidism for RAI', 'description': 'The group of patients who experience hypothyroidism after thyroid hormone withdrawal for radioactive iodine(RAI) therapy'}]}, 'contactsLocationsModule': {'locations': [{'zip': '143-729', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jee Hyun An', 'role': 'CONTACT', 'email': 'jeehyunan@gmail.com', 'phone': '82-10-9089-4655'}, {'name': 'Suk Kyoung Kim, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jee Hyun An, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ki Ho Song, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Dong Lim Kim, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Konkuk University Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Suk Kyeong Kim, MD, PhD', 'role': 'CONTACT', 'email': '20120137@kuh.ac.kr', 'phone': '82-2-2030-7531'}, {'name': 'Jee Hyun An, MD, PhD', 'role': 'CONTACT', 'email': 'jeehyunan@gmail.com', 'phone': '82-10-9089-4655'}], 'overallOfficials': [{'name': 'Suk Kyeong Kim, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Konkuk University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Konkuk University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Suk Kyeong Kim', 'investigatorAffiliation': 'Konkuk University Medical Center'}}}}