Ignite Creation Date:
2025-12-24 @ 3:00 PM
Ignite Modification Date:
2026-01-25 @ 9:30 PM
Study NCT ID:
NCT01879059
Status:
COMPLETED
Last Update Posted:
2016-02-08
First Post:
2012-01-24
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Effects of Altering Physical Activity on Cardiometabolic Health
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jthyfault@kumc.edu', 'phone': '913-588-1790', 'title': 'John P. Thyfault, PhD', 'organization': 'University of Kansas Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Exercise', 'description': '5 days of inactivity followed by a 1 day return to physical activity\n\nExercise: short period of inactivity (5 days) followed by a return to physical activity (1 day)', 'otherNumAtRisk': 13, 'otherNumAffected': 0, 'seriousNumAtRisk': 13, 'seriousNumAffected': 0}], 'frequencyThreshold': '00'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Effects of Physical Inactivity on Post Prandial Blood Flow', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Exercise', 'description': '5 days of inactivity followed by a 1 day return to physical activity\n\nExercise: short period of inactivity (5 days) followed by a return to physical activity (1 day)'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'spread': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '10 days', 'description': 'There was a pre-measurement period of 3 days, then 5 days of inactivity, followed by 1.5-2 days of return to activity. A 10 day time frame overall. Blood flow measured by Doppler ultrasound during an oral glucose tolerance test before and after 5 days of inactivity.', 'unitOfMeasure': 'percentage of change in blood flow', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'healthy, young, active men'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Exercise', 'description': '5 days of inactivity followed by a 1 day return to physical activity\n\nExercise: short period of inactivity (5 days) followed by a return to physical activity (1 day)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Exercise', 'description': '5 days of inactivity followed by a 1 day return to physical activity\n\nExercise: short period of inactivity (5 days) followed by a return to physical activity (1 day)'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '24', 'spread': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'young, healthy, active men'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-04', 'studyFirstSubmitDate': '2012-01-24', 'resultsFirstSubmitDate': '2014-10-14', 'studyFirstSubmitQcDate': '2013-06-14', 'lastUpdatePostDateStruct': {'date': '2016-02-08', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-01-04', 'studyFirstPostDateStruct': {'date': '2013-06-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-02-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effects of Physical Inactivity on Post Prandial Blood Flow', 'timeFrame': '10 days', 'description': 'There was a pre-measurement period of 3 days, then 5 days of inactivity, followed by 1.5-2 days of return to activity. A 10 day time frame overall. Blood flow measured by Doppler ultrasound during an oral glucose tolerance test before and after 5 days of inactivity.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['insulin resistance', 'exercise', 'continuous glucose monitoring', 'blood flow', 'endothelial function'], 'conditions': ['Insulin Resistance']}, 'referencesModule': {'references': [{'pmid': '21716152', 'type': 'BACKGROUND', 'citation': 'Mikus CR, Oberlin DJ, Libla JL, Taylor AM, Booth FW, Thyfault JP. Lowering physical activity impairs glycemic control in healthy volunteers. Med Sci Sports Exerc. 2012 Feb;44(2):225-31. doi: 10.1249/MSS.0b013e31822ac0c0.'}, {'pmid': '21737826', 'type': 'BACKGROUND', 'citation': 'Mikus CR, Fairfax ST, Libla JL, Boyle LJ, Vianna LC, Oberlin DJ, Uptergrove GM, Deo SH, Kim A, Kanaley JA, Fadel PJ, Thyfault JP. Seven days of aerobic exercise training improves conduit artery blood flow following glucose ingestion in patients with type 2 diabetes. J Appl Physiol (1985). 2011 Sep;111(3):657-64. doi: 10.1152/japplphysiol.00489.2011. Epub 2011 Jul 7.'}]}, 'descriptionModule': {'briefSummary': 'The effects of physical inactivity on variations in blood glucose and vascular health are not fully understood. The purpose of this study is to determine if an acute transition from physical activity to inactivity alters vascular health. Specifically, the investigators wish to examine in healthy, lean physically active individuals (obtaining greater than 10,000 steps/day) if decreasing physical activity (obtaining less than 5,000 steps/day) will alter blood flow following a meal a marker of vascular health. Furthermore, the investigators wish to examine if a one day return to physical activity (obtaining \\>10,000 steps/day) can restore the detrimental effects on blood flow following a meal.', 'detailedDescription': 'Herein, we tested the hypothesis that an acute reduction in daily activity (from \\>10,000 to \\<5,000 steps/day) for 5 days in healthy individuals reduced meal-stimulated blood flow and if a 1 day return to activity improved this outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI: less than 30 kg/m2\n* Physically active: exercise greater than 60mins per week\n\nExclusion Criteria:\n\n* smoking\n* type 2 diabetes\n* Underlying conditions that limit ability to exercise safely\n* Recent weight gain or loss(\\> 5% of body weight in 3 months)\n* Recent (\\< 3 mo) changes in medication use or dose\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT01879059', 'acronym': 'PIA', 'briefTitle': 'The Effects of Altering Physical Activity on Cardiometabolic Health', 'organization': {'class': 'OTHER', 'fullName': 'University of Kansas Medical Center'}, 'officialTitle': 'The Effects of Altering Physical Activity on Endothelial Function, Glycemic Control, and the Blood Flow Response to an Oral Glucose Tolerance Test.', 'orgStudyIdInfo': {'id': 'PIA-1200428'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exercise', 'description': '5 days of inactivity followed by a 1 day return to physical activity', 'interventionNames': ['Behavioral: Exercise']}], 'interventions': [{'name': 'Exercise', 'type': 'BEHAVIORAL', 'description': 'short period of inactivity (5 days) followed by a return to physical activity (1 day)', 'armGroupLabels': ['Exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '65211', 'city': 'Columbia', 'state': 'Missouri', 'country': 'United States', 'facility': 'University of Missouri', 'geoPoint': {'lat': 38.95171, 'lon': -92.33407}}], 'overallOfficials': [{'name': 'John P Thyfault, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Missouri-Columbia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Kansas Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}