Ignite Creation Date:
2025-12-24 @ 6:25 PM
Ignite Modification Date:
2026-02-23 @ 1:52 PM
Study NCT ID:
NCT02891668
Status:
COMPLETED
Last Update Posted:
2018-08-01
First Post:
2016-05-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hypothyroidism, Metabolism and Quality of Life - Focus on QOL, REE, Cognitive Function and Body Composition
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007037', 'term': 'Hypothyroidism'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic 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': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2018-05-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-31', 'studyFirstSubmitDate': '2016-05-17', 'studyFirstSubmitQcDate': '2016-09-01', 'lastUpdatePostDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-05-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in quality of life as measured with the ThyPro questionaire', 'timeFrame': '1 year'}, {'measure': 'Changes in resting energy expenditure in KCal/day', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Changes in Perceived Deficit Questionaire', 'timeFrame': '1 year'}, {'measure': 'Changes in insulin resistance evaluated by MATSUDA index', 'timeFrame': '1 year'}, {'measure': 'Changes in insulin resistance evaluated by HOMA index', 'timeFrame': '1 year'}, {'measure': 'Changes in cognitive tests', 'timeFrame': '1 year'}, {'measure': 'Changes in body composition asses through lean mass', 'timeFrame': '1 year'}, {'measure': 'Changes in body composition asses through visceral adipose tissue', 'timeFrame': '1 year'}, {'measure': 'Changes in body composition asses through fat mass', 'timeFrame': '1 year'}, {'measure': 'Changes in free fatty acids', 'timeFrame': '1 year'}, {'measure': 'Changes in cholesterol', 'timeFrame': '1 year'}, {'measure': 'Changes in serum triglycerides', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Basal Metabolic rate', 'Quality of life', 'Resting energy expenditure', 'Insulin resistance', 'Cognitive Function', 'Body Composition'], 'conditions': ['Hypothyroidism']}, 'referencesModule': {'references': [{'pmid': '34194721', 'type': 'DERIVED', 'citation': 'Medici BB, Lerche la Cour J, Knop FK, Krakauer M, Michaelsson LF, Faber J, Watt T, Nygaard B. Predictors of Improvement in Quality of Life When Treating Hypothyroidism. J Thyroid Res. 2021 Jun 11;2021:5577217. doi: 10.1155/2021/5577217. eCollection 2021.'}]}, 'descriptionModule': {'briefSummary': 'This project has the following primary aims:\n\nThe main objective is to delineate the association between changes in Resting energy expenditure (REE) and QOL in hypothyroid patients before and after one year of L-T4 treatment. To achieve this, the investigators plan to compare newly diagnosed hypothyroid patients soon after diagnosis before L-T4 therapy has been initiated after 6 months and after 1 year of treatment.\n\nPrimary endpoint is changes in REE compared to changes in QOL Secondary endpoint is changes in cognitive function and changes in body composition before and after one year of treatment and furthermore changes in insulin resistance following changes in body composition and free fatty acids (FFA).', 'detailedDescription': 'Subjects and Methods:\n\n74 newly diagnosed hypothyroid patients of both genders and age between 20 and 75 years will be recruited from the out-patients clinic in Herlev and Gentofte Hospital and the general practitioners before start of substitution therapy. Participants will get an appointment immediately after diagnosis to avoid unnecessary delay of treatment. Shortly after diagnosis patients will undergo a test panel at the first experimental day, where patients arrives fasting.\n\n* Psychological test using:\n\n * ThyPRO a thyroid-specific quality of life questionnaire(18),\n * Cognitive function by CALCAP® Abbreviated Test Battery,\n * Perceived cognitive deficit questionnaire (Perceived Deficits Questionaire)\n * Major Depression Inventory (MDI) questionnaire\n* REE will be measured by a CCM-express calorimeter,\n* DEXA-scan\n* Blood samples will be taken and patients will be characterized through basic information.\n* Insulin resistance will be assess through an oral glucose tolerance test (OGTT) At end of the first experimental day patients will start L-T4 therapy following national guidelines, with regular control of thyroid hormones to ensure optimal treatment. When patients are euthyroid and TSH is below 4 \\* 10-3 International Units pr liter (mU/l) patients will have blood samples monitored every 3 months for the rest of the trial.\n\nAfter 6 and 12 months of treatment patients will undergo a similar experimental day and return to their general practitioner or outpatient clinic.\n\nA control group of 18 matched healthy persons will undergo the first experimental day in the same way as the hypothyroid patients, except they do not start any kind of therapy and they only participate in the first experimental day.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Hypothyroid patients.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* TSH \\> 10 mU/liter\n\nExclusion Criteria:\n\n* Serious competing illness\n* Pregnancy or planning to become pregnant\n* Thyroidectomized patients\n* Unable to speak and understand danish'}, 'identificationModule': {'nctId': 'NCT02891668', 'acronym': 'HYMAQ', 'briefTitle': 'Hypothyroidism, Metabolism and Quality of Life - Focus on QOL, REE, Cognitive Function and Body Composition', 'organization': {'class': 'OTHER', 'fullName': 'Herlev Hospital'}, 'officialTitle': 'Hypothyroidism, Metabolism and Quality of Life - Focus on QOL, REE, Cognitive Function and Body Composition', 'orgStudyIdInfo': {'id': 'Herlev-Hymaq'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Hypothyroid', 'description': 'Levothyroxine treatment', 'interventionNames': ['Drug: Levothyroxine treatment']}, {'label': 'Healthy volunteers', 'description': 'Matched on age and BMI 18 persons'}], 'interventions': [{'name': 'Levothyroxine treatment', 'type': 'DRUG', 'otherNames': ['Eltroxin, Euthyrox'], 'description': 'Eltroxin/Euthyrox is part of the normal treatment for hypothyroidism, and the patient is treated equally, whether he/she participates or not.', 'armGroupLabels': ['Hypothyroid']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'DK-2730', 'city': 'Herlev', 'state': 'Capital Region', 'country': 'Denmark', 'facility': 'Department of internal Medicine, Herlev Hospital', 'geoPoint': {'lat': 55.72366, 'lon': 12.43998}}], 'overallOfficials': [{'name': 'Bjarke Medici, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bjarke Medici'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Herlev Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PH.d. student', 'investigatorFullName': 'Bjarke Borregaard Medici', 'investigatorAffiliation': 'Herlev Hospital'}}}}