Ignite Creation Date:
2025-12-25 @ 5:19 AM
Ignite Modification Date:
2025-12-26 @ 4:26 AM
Study NCT ID:
NCT03431727
Status:
UNKNOWN
Last Update Posted:
2020-12-07
First Post:
2017-12-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Acromegaly - Before and After Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000172', 'term': 'Acromegaly'}, {'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}], 'ancestors': [{'id': 'D001849', 'term': 'Bone Diseases, Endocrine'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D006964', 'term': 'Hyperpituitarism'}, {'id': 'D010900', 'term': 'Pituitary Diseases'}, {'id': 'D007027', 'term': 'Hypothalamic Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood samples and tissue will be kept in a locked freezer thorughout the study period'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2022-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-12-04', 'studyFirstSubmitDate': '2017-12-22', 'studyFirstSubmitQcDate': '2018-02-12', 'lastUpdatePostDateStruct': {'date': '2020-12-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sleep apnea', 'timeFrame': 'At baseline (time of diagnosis) and at an average of 1 years treatment', 'description': 'ApneaLinkAir: respiratory effort, puls, oxygen saturation, nasal flow and snoring'}, {'measure': 'Circulation', 'timeFrame': 'At baseline (time of diagnosis) and at an average of 1 years treatment', 'description': 'Sphygmocor: central arterial pressure and pulse wave velocity'}, {'measure': 'Bone metabolism', 'timeFrame': 'At baseline (time of diagnosis) and at an average of 1 years treatment', 'description': 'HRpQCT scan'}], 'secondaryOutcomes': [{'measure': 'Heartfunction', 'timeFrame': 'At baseline (time of diagnosis) and at an average of 1 years treatment', 'description': 'Echocardiography'}, {'measure': 'Substrate metabolism; signaling proteins', 'timeFrame': 'At baseline (time of diagnosis) and at an average of 1 years treatment', 'description': 'Western blotting'}, {'measure': 'Substrate metabolism; gene targets', 'timeFrame': 'At baseline (time of diagnosis) and at an average of 1 years treatment', 'description': 'qPCR'}, {'measure': 'Energy expenditure', 'timeFrame': 'At baseline (time of diagnosis) and at an average of 1 years treatment', 'description': 'Indirect calorimetry'}, {'measure': 'Body composition', 'timeFrame': 'At baseline (time of diagnosis) and at an average of 1 years treatment', 'description': 'DXA scan'}, {'measure': 'Physical activity', 'timeFrame': 'At baseline (time of diagnosis) and at an average of 1 years treatment', 'description': 'Sensoriband'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acromegaly', 'Growth Hormone Treatment', 'Sleep Apnea', 'Cardiovascular Diseases', 'Bone Diseases']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to investigate sleep apnea, circulation and metabolism in acromegaly before and after surgery and/or medical treatment.', 'detailedDescription': 'Acromegaly is a rare disease caused by a growth hormone (GH) producing pituitary adenoma. Surgery is primary treatment, whereas medical treatment with a somatostatin analogue (SA), which suppresses GH secretion and reduces tumour size, is used when surgery is insufficient or unfeasible. Acromegaly is associated with metabolic abnormalities which contributes to an increased morbidity and mortality if left untreated. To which extend these abnormalities reverses after treatment, and if treatment modality influences the outcome, remain elusive. The aim of the study is to investigate sleep apnea, circulation and metabolism in acromegaly before and after surgery and/or medical treatment'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Newly diagnosed acromegalic patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Recently diagnosed with acromegaly\n* Age above 18\n* Written consent\n\nExclusion Criteria:\n\n\\- Pregnancy'}, 'identificationModule': {'nctId': 'NCT03431727', 'briefTitle': 'Acromegaly - Before and After Treatment', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Sleep Apnea, Circulation and Metabolism in Acromegaly - Before and After Treatment', 'orgStudyIdInfo': {'id': '1-10-72-126-16'}}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Aarhus', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Mai C Arlien-Søborg, MD', 'role': 'CONTACT', 'email': 'mas@clin.au.dk', 'phone': '+45 23837420'}, {'name': 'Jens Otto L Jørgensen, Professor', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Mai C Arlien-Søborg, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Aarhus University Hospital, Department of internal medicine and endocrinologi', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}], 'centralContacts': [{'name': 'Mai C Arlien-Søborg, MD', 'role': 'CONTACT', 'email': 'mas@clin.au.dk', 'phone': '+45 23837420'}, {'name': 'Jens Otto L Jørgensen, Professor', 'role': 'CONTACT', 'email': 'joj@clin.au.dk', 'phone': '+45 24800664'}], 'overallOfficials': [{'name': 'Jens Otto L Jørgensen, Porfessor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aarhus University Hospital, Department of internal medicine and endocrinology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}