Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-26 @ 4:58 PM
Study NCT ID:
NCT05244694
Status:
COMPLETED
Last Update Posted:
2023-02-17
First Post:
2022-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Insulin on Sympathetic Nervous System-mediated Peripheral Vasoconstriction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007328', 'term': 'Insulin'}], 'ancestors': [{'id': 'D011384', 'term': 'Proinsulin'}, {'id': 'D061385', 'term': 'Insulins'}, {'id': 'D010187', 'term': 'Pancreatic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2021-06-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-16', 'studyFirstSubmitDate': '2022-02-07', 'studyFirstSubmitQcDate': '2022-02-07', 'lastUpdatePostDateStruct': {'date': '2023-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Amount of leg blood flow', 'timeFrame': 'Change from baseline at minute 60', 'description': 'Measured with Doppler ultrasound (mL/min)'}], 'secondaryOutcomes': [{'measure': 'Amount of muscle sympathetic nerve activity (MSNA)', 'timeFrame': 'Change from baseline at minute 60', 'description': 'MSNA burst incidence (bursts/100 heart beats)'}, {'measure': 'Amount of cerebral blood flow', 'timeFrame': 'Change from baseline at minute 60', 'description': 'Measured with trans-cranial Doppler ultrasound (cm/s)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Vasoconstriction', 'Healthy', 'Insulin Resistance']}, 'descriptionModule': {'briefSummary': 'The purpose of this project is to determine if hyperinsulinemia attenuates sympathetic nervous system-mediated vasoconstriction in the human leg.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy adult men and women;\n* 18-45 years of age;\n* BMI 18-30 kg/m2;\n* non-pregnant/non-breastfeeding;\n* non-nicotine users;\n\nExclusion Criteria:\n\n* taking any medications known to affect metabolic, respiratory, cardiovascular, and/or autonomic functions\n\nSelf-reported history of:\n\n* hepatic, renal, pulmonary, cardiovascular, or neurological disease;\n* stroke or neurovascular disease;\n* bleeding/clotting disorders;\n* sleep apnea or other sleep disorders;\n* diabetes;\n* smoking;\n* history of alcoholism or substance abuse, excessive alcohol consumption;\n* hypertension;\n* active cancer;\n* autoimmune disease;\n* immunosuppressant therapy'}, 'identificationModule': {'nctId': 'NCT05244694', 'briefTitle': 'Impact of Insulin on Sympathetic Nervous System-mediated Peripheral Vasoconstriction', 'organization': {'class': 'OTHER', 'fullName': 'University of Missouri-Columbia'}, 'officialTitle': 'Impact of Insulin on Sympathetic Nervous System-mediated Peripheral Vasoconstriction', 'orgStudyIdInfo': {'id': '2020286'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Insulin', 'description': 'Participants will complete a 60 minute hyperinsulinemic-euglycemic infusion.', 'interventionNames': ['Drug: Insulin']}], 'interventions': [{'name': 'Insulin', 'type': 'DRUG', 'description': 'Priming dose then a constant infusion at 40 mU•m-2•min-1', 'armGroupLabels': ['Insulin']}]}, '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 L 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'}}}}