Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-25 @ 11:54 PM
Study NCT ID:
NCT05219994
Status:
COMPLETED
Last Update Posted:
2023-07-27
First Post:
2022-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Targeting the Carotid Bodies to Reduce Disease Risk Along the Diabetes Continuum
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'After screening, participants will complete two study visits.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2023-05-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-26', 'studyFirstSubmitDate': '2022-01-21', 'studyFirstSubmitQcDate': '2022-01-21', 'lastUpdatePostDateStruct': {'date': '2023-07-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glucose change in response to OGTT', 'timeFrame': '2 hours post glucose ingestion'}, {'measure': 'Insulin change in response to OGTT', 'timeFrame': '2 hours post glucose ingestion'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'Our overall goal is to advance our understanding of the contribution of the carotid body chemoreceptors in glucose regulation and the development of type 2 diabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy,\n* type 2 diabetes\n* BMI 18-40 kg/m2,\n* non-pregnant,\n* non-breastfeeding,\n* non-nicotine users.\n\nExclusion Criteria:\n\n* cardiovascular disease including myocardial infarction, heart failure, coronary artery disease, stroke;\n* renal or hepatic diseases;\n* active cancer;\n* autoimmune diseases;\n* immunosuppressant therapy;\n* excessive alcohol consumption (\\>14 drinks/week);\n* current nicotine use;\n* foot ulcers;\n* diabetic neuropathy;\n* medication directly influencing sympathetic nervous system activity'}, 'identificationModule': {'nctId': 'NCT05219994', 'briefTitle': 'Targeting the Carotid Bodies to Reduce Disease Risk Along the Diabetes Continuum', 'organization': {'class': 'OTHER', 'fullName': 'University of Missouri-Columbia'}, 'officialTitle': 'Targeting the Carotid Bodies to Reduce Disease Risk Along the Diabetes Continuum', 'orgStudyIdInfo': {'id': '2018486'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oral Glucose Tolerance Test', 'description': 'Subjects will consume a 75 g glucose drink within 1-min and monitored for 2 hours.', 'interventionNames': ['Other: Hyperoxia Exposure', 'Other: Normoxia Exposure']}], 'interventions': [{'name': 'Hyperoxia Exposure', 'type': 'OTHER', 'description': '2 hours of hyperoxia exposure during OGTT', 'armGroupLabels': ['Oral Glucose Tolerance Test']}, {'name': 'Normoxia Exposure', 'type': 'OTHER', 'description': '2 hours of normoxia exposure during OGTT', 'armGroupLabels': ['Oral Glucose Tolerance Test']}]}, 'contactsLocationsModule': {'locations': [{'zip': '65211', 'city': 'Columbia', 'state': 'Missouri', 'country': 'United States', 'facility': 'University of Missouri', 'geoPoint': {'lat': 38.95171, 'lon': -92.33407}}], 'overallOfficials': [{'name': 'Jacqueline Limberg, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Missouri-Columbia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Missouri-Columbia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Jacqueline K Limberg, PhD', 'investigatorAffiliation': 'University of Missouri-Columbia'}}}}