Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-27 @ 11:46 PM
Study NCT ID:
NCT06882460
Status:
RECRUITING
Last Update Posted:
2025-07-29
First Post:
2024-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diet and Exercise Solutions to Postprandial Hypotension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 13}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-24', 'studyFirstSubmitDate': '2024-12-12', 'studyFirstSubmitQcDate': '2025-03-12', 'lastUpdatePostDateStruct': {'date': '2025-07-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Magnitude of systolic blood pressure decrease (in-lab)', 'timeFrame': 'Visit 2-4, Day 1', 'description': 'Calculated as the maximum decrease in systolic blood pressure in the 2-h after eating breakfast and lunch under laboratory-controlled conditions'}], 'secondaryOutcomes': [{'measure': 'Magnitude of systolic blood pressure decrease (at-home)', 'timeFrame': 'Visits 2-4, Days 1-3', 'description': 'Calculated as the maximum decrease in systolic blood pressure in the 2-h after eating breakfast, lunch, and dinner for 3-days during at-home testing'}, {'measure': 'Postprandial glucose (in-lab)', 'timeFrame': 'Visits 2-4, Day 1', 'description': 'Blood samples will be obtained from an intravenous catheter at regular intervals after eating breakfast (3-h) and lunch (2-h) under laboratory controlled conditions.'}, {'measure': 'Postprandial insulin (in-lab)', 'timeFrame': 'Visits 2-4, Day 1', 'description': 'Blood samples will be obtained from an intravenous catheter at regular intervals after eating breakfast (3-h) and lunch (2-h) under laboratory controlled conditions.'}, {'measure': 'Postprandial glucose (at-home)', 'timeFrame': 'Visits 2-4, Day 1-3', 'description': 'A continuous glucose monitor will be used to measure glucose for 2-h after breakfast, lunch, and dinner for 3-days during at-home testing'}, {'measure': 'Blood flow (in-lab)', 'timeFrame': 'Visits 2-4, Day 1', 'description': 'Blood flow at the radial, brachial, popliteal and superior mesenteric arteries will be obtained using Doppler imaging at regular intervals after eating breakfast (3-h) and lunch (2-h) under laboratory controlled conditions.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['postprandial hypotension', 'electrical stimulation', 'low-glycemic diet'], 'conditions': ['Spinal Cord Injuries']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if a low glycemic diet and lower-body electrical stimulation can reduce postprandial hypotension in individuals with chronic spinal cord injury.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Spinal cord injury (SCI) between C4 and T12 who require use of wheelchair for daily mobility\n* AIS A or B\n* \\>1-year post-injury\n\nExclusion Criteria:\n\n* Currently pregnant of breast-feeding\n* Type 1 or 2 diabetes\n* Previous gut augmentation bariatric surgery\n* Neurological impairment other than SCI\n* History of uncontrolled autonomic dysreflexia\n* History of bone fractures\n* Use of abdominal binder or anti-hypotensive drugs\n* Fitted with pacemaker or defibrillator\n* Currently receiving electrical stimulation training or in the previous year'}, 'identificationModule': {'nctId': 'NCT06882460', 'briefTitle': 'Diet and Exercise Solutions to Postprandial Hypotension', 'organization': {'class': 'OTHER', 'fullName': 'Ohio State University'}, 'officialTitle': 'Lifestyle Solutions to Postprandial Hypotension in Spinal Cord Injury', 'orgStudyIdInfo': {'id': '2024H0147'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'High glycemic load', 'interventionNames': ['Other: High glycemic load diet']}, {'type': 'EXPERIMENTAL', 'label': 'Low glycemic load', 'interventionNames': ['Other: Low glycemic load']}, {'type': 'EXPERIMENTAL', 'label': 'Electrical Stimulation', 'interventionNames': ['Other: Electrical stimulation exercise', 'Other: High glycemic load diet']}], 'interventions': [{'name': 'Low glycemic load', 'type': 'OTHER', 'description': 'Low glycemic load diet', 'armGroupLabels': ['Low glycemic load']}, {'name': 'Electrical stimulation exercise', 'type': 'OTHER', 'description': 'Lower-body electrical stimulation exercise for 1-h after eating', 'armGroupLabels': ['Electrical Stimulation']}, {'name': 'High glycemic load diet', 'type': 'OTHER', 'description': 'High glycemic load diet', 'armGroupLabels': ['Electrical Stimulation', 'High glycemic load']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Matthew Farrow', 'role': 'CONTACT', 'email': 'Matthew.Farrow@osumc.edu'}], 'facility': 'Dodd Rehabilitation Hospital', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'centralContacts': [{'name': 'Matthew Farrow, PhD', 'role': 'CONTACT', 'email': 'Matthew.Farrow@osumc.edu', 'phone': '614-293-2812'}, {'name': 'Ceren Yarar-Fisher, PhD', 'role': 'CONTACT', 'email': 'Ceren.Yarar-Fisher@osumc.edu'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ohio State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ceren Yarar-Fisher', 'investigatorAffiliation': 'The Craig H. Neilsen Foundation'}}}}