Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2025-12-26 @ 10:58 AM
Study NCT ID:
NCT05838508
Status:
RECRUITING
Last Update Posted:
2025-06-13
First Post:
2023-04-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Physical Activity Pattern on Cardiometabolic Health
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 26}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-11', 'studyFirstSubmitDate': '2023-04-07', 'studyFirstSubmitQcDate': '2023-04-28', 'lastUpdatePostDateStruct': {'date': '2025-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'resting energy expenditure', 'timeFrame': '24-hour test period after exercise', 'description': 'energy expenditure will be measured at 1-2 hours interval by indirect calorimetry'}, {'measure': 'respiratory exchange ratio', 'timeFrame': '24-hour test period after exercise', 'description': 'respiratory exchange ratio will be measured at 1-2 hours interval by indirect calorimetry'}], 'primaryOutcomes': [{'measure': 'glucose level', 'timeFrame': '24-hour test period after exercise', 'description': 'mean glucose level after exercise session'}, {'measure': 'mean arterial pressure', 'timeFrame': '24-hour test period after exercise', 'description': 'mean arterial pressure after exercise session'}], 'secondaryOutcomes': [{'measure': 'insulin sensitivity index', 'timeFrame': 'about 12 and 24 hours after exercise', 'description': 'Oral Minimal Model method estimates mean insulin sensitivity based on blood glucose and insulin levels from two mixed meal tests after exercise session'}, {'measure': 'beta-cell function index', 'timeFrame': 'about 12 and 24 hours after exercise', 'description': 'Oral Minimal Model method estimates mean beta-cell function based on blood glucose, insulin and c-peptide levels from two mixed meal tests after exercise session'}, {'measure': 'total peripheral resistance', 'timeFrame': '24-hour test period after exercise', 'description': 'total peripheral resistance derived from BP waveform measured by finger plethysmography'}, {'measure': 'autonomic nervous system activity', 'timeFrame': '24-hour test period after exercise', 'description': 'derived by time-domain heart rate variability analysis'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['exercise', 'circadian system', 'physical activity', 'glucose tolerance', 'blood pressure'], 'conditions': ['Life Style']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to understand the interaction between the circadian system and physical activity.\n\nParticipants will:\n\n* complete 2 inpatient stays\n* perform moderate exercise\n* be provided with identical meals\n* have frequent blood draws\n* provide urine and saliva samples', 'detailedDescription': 'The endogenous circadian system (i.e., an internal biological rhythm) plays an important role in regulating blood glucose, blood pressure, and energy expenditure. Physical activity improves health and reduces the risk for cardiovascular diseases and type 2 diabetes. The goal of this study is to understand the interaction between the circadian system and physical activity. We aim to test whether such relationship between the circadian system and physical activity can be used to enhance the health benefits of physical activity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-45 yr old\n* Body mass index (BMI) 18.5 - 34.9 kg/m2\n* No acute, chronic or debilitating medical conditions (e.g. metabolic, cardiovascular, respiratory, neurological, cancers, etc.)\n* Willing to adhere to the protocol requirements for the duration of the study\n\nExclusion Criteria:\n\n* Currently smoking/vaping or 5 or more years of smoking/vaping\n* Currently pregnant or breastfeeding\n* History of drug or alcohol dependency\n* History of psychiatric illness or disorder\n* Any hospitalization due to COVID-19\n* Inability to exercise for any reason\n* Any known contraindication to exercise testing based on current ACSM guidelines'}, 'identificationModule': {'nctId': 'NCT05838508', 'acronym': 'PACE', 'briefTitle': 'Effect of Physical Activity Pattern on Cardiometabolic Health', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': 'Effect of Physical Activity Pattern on Cardiometabolic Health', 'orgStudyIdInfo': {'id': '2023P001025'}, 'secondaryIdInfos': [{'id': 'R00HL148500', 'link': 'https://reporter.nih.gov/quickSearch/R00HL148500', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exercise A-B Intervention', 'description': 'The Exercise A first, then the Exercise B intervention.', 'interventionNames': ['Behavioral: Exercise intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Exercise B-A Intervention', 'description': 'The Exercise B first, then the Exercise A intervention.', 'interventionNames': ['Behavioral: Exercise intervention']}], 'interventions': [{'name': 'Exercise intervention', 'type': 'BEHAVIORAL', 'description': 'Research participants will be assigned to two exercise conditions.', 'armGroupLabels': ['Exercise A-B Intervention', 'Exercise B-A Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jingyi Qian, PhD', 'role': 'CONTACT', 'email': 'jqian@bwh.harvard.edu', 'phone': '6175257423'}, {'name': 'Vy Nguyen, B.S.', 'role': 'CONTACT', 'email': 'vnguyen42@bwh.harvard.edu', 'phone': '617-525-0662'}, {'name': 'Frank Scheer, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jingyi Qian, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'centralContacts': [{'name': 'Jingyi Qian, PhD', 'role': 'CONTACT', 'email': 'jqian@bwh.harvard.edu', 'phone': '6175257423'}, {'name': 'Vy Nguyen, B.S.', 'role': 'CONTACT', 'email': 'vnguyen42@bwh.harvard.edu', 'phone': '617-525-0662'}], 'overallOfficials': [{'name': 'Jingyi Qian, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Brigham and Women's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Investigator', 'investigatorFullName': 'Jingyi Qian', 'investigatorAffiliation': "Brigham and Women's Hospital"}}}}