Ignite Creation Date:
2025-12-24 @ 1:00 PM
Ignite Modification Date:
2026-01-24 @ 2:15 PM
Study NCT ID:
NCT03160261
Status:
COMPLETED
Last Update Posted:
2018-05-03
First Post:
2017-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Exenatide on Cortisol Secretion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077270', 'term': 'Exenatide'}], 'ancestors': [{'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D014688', 'term': 'Venoms'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D014118', 'term': 'Toxins, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single-group, open-label'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2017-12-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-02', 'studyFirstSubmitDate': '2017-04-24', 'studyFirstSubmitQcDate': '2017-05-17', 'lastUpdatePostDateStruct': {'date': '2018-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'heart rate', 'timeFrame': 'every 30 minutes during 2 hours after injection', 'description': 'Change in heart rate'}, {'measure': 'Blood pressure', 'timeFrame': 'every 30 minutes during 2 hours after injection', 'description': 'Change in blood pressure'}, {'measure': 'nausea', 'timeFrame': 'every 30 minutes during 2 hours after injection', 'description': 'intensity of nausea in visual analogue scale'}], 'primaryOutcomes': [{'measure': 'Cortisol peak', 'timeFrame': 'every 30 minutes during 2 hours after injection', 'description': 'Maximum concentration achieved after exenatide dose (any timepoint after injection)'}], 'secondaryOutcomes': [{'measure': 'Adrenocorticotropin (ACTH) peak', 'timeFrame': 'every 30 minutes during 2 hours after injection', 'description': 'Maximum concentration achieved after exenatide dose (any timepoint after injection)'}, {'measure': 'Glucose', 'timeFrame': 'Glucose measured every 30 minutes during 2 hours after injection', 'description': "Glucose values' area under the curve"}, {'measure': 'Growth hormone', 'timeFrame': 'every 30 minutes during 2 hours after injection', 'description': 'Maximum concentration achieved after exenatide dose (any timepoint after injection)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '36800161', 'type': 'DERIVED', 'citation': 'Heinla K, Vasar E, Reppo I, Sedman T, Volke V. GLP-1 Receptor Agonists Induce Growth Hormone Secretion in Healthy Volunteers. Diabetes Ther. 2023 Apr;14(4):777-786. doi: 10.1007/s13300-023-01381-w. Epub 2023 Feb 17.'}]}, 'descriptionModule': {'briefSummary': 'The primary aim of the study is to describe the effect of single dose of 10 micrograms (μg) exenatide given subcutaneously (s/c) on cortisol secretion. Secondary outcomes involve ACTH and glucose levels.', 'detailedDescription': 'Exenatide is a short-acting Glucagon-Like Peptide receptor 1 (GLP-1 R) agonist.\n\nThe clinical trial is conducted in10 healthy volunteers. Each subject receives one dose of subcutaneous exenatide (10 μg). After that, hormonal and physiological changes are measured during two hours. The blood samples are taken in 30-minute intervals.\n\nThe primary endpoint is peak value of cortisol achieved during the 2 hours after drug administration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-50 years\n* Body weight \\>65 kg\n\nExclusion Criteria:\n\n* Presence of chronic illness\n* daily use of any medicines\n* pregnancy, lactation\n* use of oral contraceptives during previous 2 months'}, 'identificationModule': {'nctId': 'NCT03160261', 'briefTitle': 'Effect of Exenatide on Cortisol Secretion', 'organization': {'class': 'OTHER', 'fullName': 'University of Tartu'}, 'officialTitle': 'Effect of Exenatide on Cortisol Secretion', 'orgStudyIdInfo': {'id': 'Ex17'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exenatide', 'description': 'Single injection of 10 μg Exenatide subcutaneously.', 'interventionNames': ['Drug: Exenatide Injection']}], 'interventions': [{'name': 'Exenatide Injection', 'type': 'DRUG', 'description': 'Single injection of Exenatide 10μg subcutaneously', 'armGroupLabels': ['Exenatide']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tartu', 'country': 'Estonia', 'facility': 'Tartu University Hospital', 'geoPoint': {'lat': 58.38062, 'lon': 26.72509}}], 'overallOfficials': [{'name': 'Vallo Volke, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Tartu'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Tartu', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Vallo Volke', 'investigatorAffiliation': 'University of Tartu'}}}}