Ignite Creation Date:
2025-12-24 @ 2:47 PM
Ignite Modification Date:
2026-03-15 @ 6:05 PM
Study NCT ID:
NCT03823859
Status:
COMPLETED
Last Update Posted:
2022-05-17
First Post:
2019-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Metabolomics of Thyroid Hormones
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007037', 'term': 'Hypothyroidism'}, {'id': 'D006980', 'term': 'Hyperthyroidism'}], 'ancestors': [{'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015502', 'term': 'Absorptiometry, Photon'}, {'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D011859', 'term': 'Radiography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003720', 'term': 'Densitometry'}, {'id': 'D010783', 'term': 'Photometry'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Serum and plasma'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 332}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-16', 'studyFirstSubmitDate': '2019-01-28', 'studyFirstSubmitQcDate': '2019-01-28', 'lastUpdatePostDateStruct': {'date': '2022-05-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Metabolome signature of thyroid Hormone Status (MSTH)', 'timeFrame': 'baseline/single visit', 'description': 'The MSTH will be tested against the current standard of diagnosis which is serum TSH level by multiple linear regression.'}], 'secondaryOutcomes': [{'measure': 'Resting energy expenditure (REE)', 'timeFrame': 'baseline/single visit', 'description': 'Comparison of REE of healthy volunteers and Patients with thyroid dysfunction, measured by indirect calorimetry.'}, {'measure': 'Body composition concerning muscle mass', 'timeFrame': 'baseline/single visit', 'description': 'Comparison of muscle mass of healthy volunteers and patients with thyroid dysfunction, measured by DXA'}, {'measure': 'Body composition concerning fat mass', 'timeFrame': 'baseline/single visit', 'description': 'Comparison of fat mass of healthy volunteers and patients with thyroid dysfunction, measured by DXA'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hypothyroidism', 'Metabolomics', 'Thyroid Hormones', 'Hyperthyroidism'], 'conditions': ['Central Hypothyroidism', 'Hypothyroidism', 'Hyperthyroidism']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to develop a metabolome signature of thyroid hormone status. The metabolome signature could be useful in diagnosis and treatment of thyroid dysfunction diseases, especially in cases where TSH cannot be reliably used.', 'detailedDescription': 'Primary Hypothyroidism is a frequent endocrine disorder, where the thyroid gland does not produce sufficient amounts of thyroid hormones. The substitution therapy is guided by measurement of the pituitary gland hormone thyrotropin (TSH). Patients with central hypothyroidism in whom pituitary insufficiency leads to hypothyroidism, TSH cannot be used to guide therapy. So far there are no reliable methods for therapy control in patients with central hypothyroidism.\n\nThe measurement of small endogenous metabolites might give investigators a metabolomics profile. This could help to discriminate between euthyroid, hypothyroid and hyperthyroid state and therefore could be used for diagnosis and therapy control of thyroid dysfunction diseases.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy volunteers will be recruited by means of advertisements (online or in the newspaper).\n\nPatients will be recruited from the endocrinology outpatient clinics of the Department of Endocrinology, Diabetes and Metabolism, University Hospital Basel and patients referred from practicing endocrinologists.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll participants:\n\n* Age 18 to 80 years\n* BMI 19 to 35 kg/m2\n* Informed consent as documented by signature\n\nA) Patients with primary hyperthyroidism TSH \\< 0.2 mIU/l and free thyroxine (fT4) \\> 25 pM or fT3 \\> 8 pM\n\nB) Patients with primary hypothyroidism, currently not sufficiently substituted TSH \\> 8 milli-International unit (mIU)/l or fT4 \\< 10 pM\n\nC) Patients with diagnosis of primary hypothyroidism, sufficiently substituted Documented diagnosis of primary hypothyroidism Substitution with L-Thyroxin TSH in target range between 0.5 and 2.5 mIU/l\n\nD) Patients with secondary hypothyroidism Pituitary disease with documented secondary hypothyroidism\n\nExclusion Criteria:\n\n* Diabetes mellitus (HbA1c \\>6.5%)\n* Severe concomitant diseases: chronic heart failure, liver cirrhosis, kidney failure, active cancer\n* Abuse of alcohol or illicit drugs\n* Women who are pregnant or breast feeding\n* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant\n* Previous enrolment into the current study'}, 'identificationModule': {'nctId': 'NCT03823859', 'acronym': 'MATcH', 'briefTitle': 'Metabolomics of Thyroid Hormones', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'Metabolomics of Thyroid Hormones', 'orgStudyIdInfo': {'id': 'EKNZ 2018-01961'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy volunteers', 'description': '* Blood sampling (fT3, fT4, TSH, Lipids, Glucose, HbA1c)\n* Indirect calorimetry\n* Dual energy X-ray Absorptiometry (DXA)', 'interventionNames': ['Diagnostic Test: Indirect calorimetry', 'Diagnostic Test: Dual energy X-ray Absorptiometry (DXA)', 'Diagnostic Test: Blood sampling']}, {'label': 'Patients with thyroid dysfunction', 'description': 'Patients with Primary hypothyroidism newly diagnosed, Primary hypothyroidism substituted, hyperthyroidism, secondary hypothyroidism\n\n* Blood sampling (fT3, fT4, TSH, Lipids, Glucose, HbA1c)\n* Indirect calorimetry\n* Dual energy X-ray Absorptiometry (DXA)', 'interventionNames': ['Diagnostic Test: Indirect calorimetry', 'Diagnostic Test: Dual energy X-ray Absorptiometry (DXA)', 'Diagnostic Test: Blood sampling']}], 'interventions': [{'name': 'Indirect calorimetry', 'type': 'DIAGNOSTIC_TEST', 'description': 'Resting energy expenditure', 'armGroupLabels': ['Healthy volunteers', 'Patients with thyroid dysfunction']}, {'name': 'Dual energy X-ray Absorptiometry (DXA)', 'type': 'DIAGNOSTIC_TEST', 'description': 'Body composition', 'armGroupLabels': ['Healthy volunteers', 'Patients with thyroid dysfunction']}, {'name': 'Blood sampling', 'type': 'DIAGNOSTIC_TEST', 'description': 'fT4, fT3, TSH, HDL, LDL, triglycerides, cholesterol, HbA1c, Glucose Thyroid panel', 'armGroupLabels': ['Healthy volunteers', 'Patients with thyroid dysfunction']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4031', 'city': 'Basel', 'state': 'Canton of Basel-City', 'country': 'Switzerland', 'facility': 'University Hospital Basel, Department of Endocrinology', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Matthias Betz, PD Dr. med.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Klinik Endokrinologie, Diabetes und Metabolismus'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'collaborators': [{'name': 'ETH Zurich', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}