Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2025-12-25 @ 9:23 PM
Study NCT ID:
NCT05300256
Status:
RECRUITING
Last Update Posted:
2024-04-30
First Post:
2022-03-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Peripheral Heating and Glucose Tolerance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-29', 'studyFirstSubmitDate': '2022-03-18', 'studyFirstSubmitQcDate': '2022-03-18', 'lastUpdatePostDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glucose concentrations', 'timeFrame': '1 hour'}], 'secondaryOutcomes': [{'measure': 'Insulin concentrations', 'timeFrame': '1 hour'}, {'measure': 'Blood flow', 'timeFrame': '1 hour'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Glucose Tolerance']}, 'descriptionModule': {'briefSummary': 'Effect of peripheral heating on glucose tolerance'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-80 years\n\nExclusion Criteria:\n\n* Open wounds on feet or legs\n* Peripheral neuropathy'}, 'identificationModule': {'nctId': 'NCT05300256', 'briefTitle': 'Peripheral Heating and Glucose Tolerance', 'organization': {'class': 'OTHER', 'fullName': 'San Diego State University'}, 'officialTitle': 'Peripheral Heating and Glucose Tolerance', 'orgStudyIdInfo': {'id': 'PHTGLUCOSE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Peripheral Heating', 'description': 'Peripheral Heating', 'interventionNames': ['Device: Peripheral Heating']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham', 'description': 'Sham', 'interventionNames': ['Device: Sham']}], 'interventions': [{'name': 'Peripheral Heating', 'type': 'DEVICE', 'description': 'Peripheral heating of the feet', 'armGroupLabels': ['Peripheral Heating']}, {'name': 'Sham', 'type': 'DEVICE', 'description': 'Sham', 'armGroupLabels': ['Sham']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92182', 'city': 'San Diego', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jeff Moore', 'role': 'CONTACT', 'email': 'Jmoore714@gmail.com', 'phone': '714-658-7215'}], 'facility': 'San Diego State University', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}], 'centralContacts': [{'name': 'Jeff Moore', 'role': 'CONTACT', 'email': 'Jmoore714@gmail.com', 'phone': '7146587215'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'San Diego State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Adjunct Professor', 'investigatorFullName': 'Jeffrey Moore', 'investigatorAffiliation': 'San Diego State University'}}}}