Ignite Creation Date:
2025-12-24 @ 6:32 PM
Ignite Modification Date:
2025-12-24 @ 6:32 PM
Study NCT ID:
NCT04180657
Status:
UNKNOWN
Last Update Posted:
2019-11-27
First Post:
2019-10-21
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ghrelin Levels in Patients With Protein C Deficiency
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020151', 'term': 'Protein C Deficiency'}], 'ancestors': [{'id': 'D025861', 'term': 'Blood Coagulation Disorders, Inherited'}, {'id': 'D001778', 'term': 'Blood Coagulation Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D019851', 'term': 'Thrombophilia'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'serum, plasma'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2020-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-11-25', 'studyFirstSubmitDate': '2019-10-21', 'studyFirstSubmitQcDate': '2019-11-25', 'lastUpdatePostDateStruct': {'date': '2019-11-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'acyl ghrelin and des acyl ghrelin measured in mg/dl', 'timeFrame': '6 month'}], 'secondaryOutcomes': [{'measure': 'Growth hormone measured in pmol/L', 'timeFrame': '6 month'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ghrelin', 'growth hormone', 'protein C deficiency', 'appetite'], 'conditions': ['Protein C Deficiency']}, 'descriptionModule': {'briefSummary': 'In rodents with protein C deficiency elevated levels of ghrelin has been observed. The purpose of this study is to investigate if patients with protein C deficiency also have elevated levels of ghrelin, and if so, how this affects the patients.\n\n30 patients with protein C deficiency and 30 healthy BMI and gender matched controls are recruited. Bloodsamples are taken in order to measure ghrelin and GH levels and other metabolic parameters. The patients and controls are also asked to answer a questionaire regarding appetite.\n\nIf patients with protein C deficiency have higher levels of ghrelin than the general population, this will lead to new studies that will perhaps help us understand the importance of ghrelin in humans.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with protein C deficiency and gender and BMI matched controls.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* protein C deficiency or healthy subjects\n* age 18-70\n* BMI 18-35\n* written statement to join the study\n\nExclusion Criteria:\n\n* chronic illness, apart from protein C deficiency and lifestyle diseases\n* everyday medication apart from statins, oral diabetes medication and antihypertensive drugs.\n* blood donation within three months prior to the investigation.\n* Alcohol abuse'}, 'identificationModule': {'nctId': 'NCT04180657', 'briefTitle': 'Ghrelin Levels in Patients With Protein C Deficiency', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Investigation of Ghrelin Levels in Patients With Protein C Deficiency', 'orgStudyIdInfo': {'id': '69965'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with protein C deficiency', 'description': 'Patient and control group are compared regarding ghrelin, growth hormone levels and appetite, and no other intervention is made.', 'interventionNames': ['Genetic: Protein C deficiency']}, {'label': 'Healthy controls', 'description': 'Patient and control group are compared regarding ghrelin, growth hormone levels and appetite, and no other intervention is made.'}], 'interventions': [{'name': 'Protein C deficiency', 'type': 'GENETIC', 'description': 'The effect of protein C deficiency on ghrelin levels are investigated.', 'armGroupLabels': ['Patients with protein C deficiency']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Sascha S Horup, MD', 'role': 'CONTACT', 'email': 'SASHOR@rm.dk', 'phone': '+45 27149089'}, {'name': 'Rakel F Johansen, MD', 'role': 'CONTACT', 'email': 'rfjohansen@clin.au.dk'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}