Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2025-12-25 @ 8:34 PM
Study NCT ID:
NCT03560869
Status:
COMPLETED
Last Update Posted:
2021-01-27
First Post:
2018-06-06
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
The Effect of Acute Mild Dehydration on Blood Pressure Control
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003681', 'term': 'Dehydration'}], 'ancestors': [{'id': 'D014883', 'term': 'Water-Electrolyte Imbalance'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'wbf@udel.edu', 'phone': '302-831-6178', 'title': 'William B. Farquhar', 'organization': 'University of Delaware'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data were monitored throughout the study (during experimental protocol #1 (3 days), study visit #1 (1 day), washout (up to 60 days), experimental protocol #2 (3 days), study visit #2 (1 day), and the week (7 days) following this final study visit - i.e., up to 75 days).', 'description': 'There were no adverse events, thus, there are no adverse event outcomes reported.', 'eventGroups': [{'id': 'EG000', 'title': 'Normal Hydration', 'description': 'Participants will consume water to maintain proper hydration for three days prior to testing.\n\nHydration State: Hydration State', 'otherNumAtRisk': 35, 'deathsNumAtRisk': 35, 'otherNumAffected': 0, 'seriousNumAtRisk': 35, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Dehydration', 'description': 'Participants will reduce water intake over three days and abstain from any water for the final 16 hours prior to testing.\n\nHydration State: Hydration State', 'otherNumAtRisk': 35, 'deathsNumAtRisk': 35, 'otherNumAffected': 0, 'seriousNumAtRisk': 35, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Blood Pressure Variability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Normal Hydration', 'description': 'Participants will consume water to maintain proper hydration for three days prior to testing.\n\nHydration State: Hydration State'}, {'id': 'OG001', 'title': 'Dehydration', 'description': 'Participants will reduce water intake over three days and abstain from any water for the final 16 hours prior to testing.\n\nHydration State: Hydration State'}], 'classes': [{'categories': [{'measurements': [{'value': '2.6', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '0.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During experimental visits 1 and 2', 'description': 'Blood pressure variability (BPV) was calculated using standard deviation and using the average real variability index of blood pressure values. The average real variability index calculates the average of absolute differences between consecutive BP measurements and is thought to provide further prognostic value compared with traditional measures of BPV.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Blood Pressure Reactivity - Handgrip Exercise', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Normal Hydration', 'description': 'Participants will consume water to maintain proper hydration for three days prior to testing.\n\nHydration State: Hydration State'}, {'id': 'OG001', 'title': 'Dehydration', 'description': 'Participants will reduce water intake over three days and abstain from any water for the final 16 hours prior to testing.\n\nHydration State: Hydration State'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'spread': '11', 'groupId': 'OG000'}, {'value': '18', 'spread': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During experimental visits 1 and 2', 'description': 'Change in systolic blood pressure during the second-minute handgrip exercise minus compared to pre-exercise baseline (i.e., at rest).', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '4 adults were excluded from this analysis due to technical difficulties'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Normal Hydration Than Dehydration', 'description': '14 participants consumed water to maintain proper hydration for three days prior to testing (visit 1). Seven to 60 days later, participants reduced water intake over three days and abstained from any water for the final 16 hours prior to testing (visit 2).'}, {'id': 'FG001', 'title': 'Dehydration Than Normal Hydration', 'description': '21 participants reduced water intake over three days and abstained from any water for the final 16 hours prior to testing (visit 1). Seven to 60 days later, participants consumed water to maintain proper hydration for three days prior to testing (visit 2).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Screening failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Withdrawal by PI', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'All participants completed both conditions.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Study Participants', 'description': 'All Study Participants'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '47', 'spread': '22', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '27', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '35', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '28', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'noSap': True, 'largeDocs': [{'date': '2018-07-19', 'size': 841297, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-03-24T15:03', 'hasProtocol': False}, {'date': '2019-03-06', 'size': 309836, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-11-09T12:48', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Normal Hydration and Dehydration'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2019-06-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-05', 'studyFirstSubmitDate': '2018-06-06', 'resultsFirstSubmitDate': '2020-10-05', 'studyFirstSubmitQcDate': '2018-06-06', 'lastUpdatePostDateStruct': {'date': '2021-01-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-01-05', 'studyFirstPostDateStruct': {'date': '2018-06-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood Pressure Variability', 'timeFrame': 'During experimental visits 1 and 2', 'description': 'Blood pressure variability (BPV) was calculated using standard deviation and using the average real variability index of blood pressure values. The average real variability index calculates the average of absolute differences between consecutive BP measurements and is thought to provide further prognostic value compared with traditional measures of BPV.'}, {'measure': 'Blood Pressure Reactivity - Handgrip Exercise', 'timeFrame': 'During experimental visits 1 and 2', 'description': 'Change in systolic blood pressure during the second-minute handgrip exercise minus compared to pre-exercise baseline (i.e., at rest).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dehydration'], 'conditions': ['Mild Dehydration']}, 'referencesModule': {'references': [{'pmid': '31617739', 'type': 'RESULT', 'citation': 'Watso JC, Robinson AT, Babcock MC, Migdal KU, Wenner MM, Stocker SD, Farquhar WB. Short-term water deprivation does not increase blood pressure variability or impair neurovascular function in healthy young adults. Am J Physiol Regul Integr Comp Physiol. 2020 Jan 1;318(1):R112-R121. doi: 10.1152/ajpregu.00149.2019. Epub 2019 Oct 16.'}, {'pmid': '31070954', 'type': 'RESULT', 'citation': 'Watso JC, Babcock MC, Robinson AT, Migdal KU, Wenner MM, Stocker SD, Farquhar WB. Water deprivation does not augment sympathetic or pressor responses to sciatic afferent nerve stimulation in rats or to static exercise in humans. J Appl Physiol (1985). 2019 Jul 1;127(1):235-245. doi: 10.1152/japplphysiol.00005.2019. Epub 2019 May 9.'}, {'pmid': '30794437', 'type': 'RESULT', 'citation': 'Robinson AT, Babcock MC, Watso JC, Brian MS, Migdal KU, Wenner MM, Farquhar WB. Relation between resting sympathetic outflow and vasoconstrictor responses to sympathetic nerve bursts: sex differences in healthy young adults. Am J Physiol Regul Integr Comp Physiol. 2019 May 1;316(5):R463-R471. doi: 10.1152/ajpregu.00305.2018. Epub 2019 Feb 22.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this project is determine how acute mild dehydration impacts blood pressure control at rest and during static exercise. This protocol will test healthy young and older adults in a normally hydrated and dehydrated condition.', 'detailedDescription': 'The purpose of this project is determine how acute mild dehydration impacts blood pressure control at rest and during static exercise. Additionally, we will determine whether or not the sympathetic nervous system has a role in mediating blood pressure control at rest and during static exercise. This protocol will test healthy young and older adults in a normally hydrated and dehydrated condition. This will allow for a within participant comparison. Additionally, we will later determine if age alters blood pressure control at rest or during static exercise.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria (Young):\n\n• age: 20-35 years old\n\nExclusion Criteria (Young):\n\n* high blood pressure (\\>140/90 mmHg)\n* history of cardiovascular disease\n* history of cancer\n* history of diabetes\n* history of kidney disease\n* obesity (BMI \\> 30 kg/m2)\n* smoking or tobacco use\n* current pregnancy\n* nursing mothers\n* communication barriers\n\nInclusion Criteria (Older):\n\n* age: 60-75 years old\n* ECG within normal limits\n* screening blood panel within normal limits\n\nExclusion Criteria (Older):\n\n* high blood pressure (\\>140/90 mmHg)\n* history of cardiovascular disease\n* history of cancer\n* history of diabetes\n* history of kidney disease\n* obesity (BMI \\> 30 kg/m2)\n* smoking or tobacco use\n* current pregnancy\n* nursing mothers\n* communication barriers'}, 'identificationModule': {'nctId': 'NCT03560869', 'briefTitle': 'The Effect of Acute Mild Dehydration on Blood Pressure Control', 'organization': {'class': 'OTHER', 'fullName': 'University of Delaware'}, 'officialTitle': 'Sympathetic Reactivity to Water Restriction in Young and Older Adults', 'orgStudyIdInfo': {'id': '1097747'}, 'secondaryIdInfos': [{'id': 'R01HL128388', 'link': 'https://reporter.nih.gov/quickSearch/R01HL128388', 'type': 'NIH'}, {'id': '5P20GM113125', 'link': 'https://reporter.nih.gov/quickSearch/5P20GM113125', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Normal hydration then dehydration', 'description': 'Participants will consume water to maintain proper hydration for three days prior to testing (visit 1). Seven to 60 days later, participants will reduce water intake over three days and abstain from any water for the final 16 hours prior to testing (visit 2).', 'interventionNames': ['Other: Normal hydration', 'Other: Dehydration']}, {'type': 'EXPERIMENTAL', 'label': 'Dehydration than normal hydration', 'description': 'Participants will reduce water intake over three days and abstain from any water for the final 16 hours prior to testing (visit 1). Seven to 60 days later, participants will consume water to maintain proper hydration for three days prior to testing (visit 2).', 'interventionNames': ['Other: Normal hydration', 'Other: Dehydration']}], 'interventions': [{'name': 'Normal hydration', 'type': 'OTHER', 'description': "see description in 'arms'", 'armGroupLabels': ['Dehydration than normal hydration', 'Normal hydration then dehydration']}, {'name': 'Dehydration', 'type': 'OTHER', 'description': "see description in 'arms'", 'armGroupLabels': ['Dehydration than normal hydration', 'Normal hydration then dehydration']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19713', 'city': 'Newark', 'state': 'Delaware', 'country': 'United States', 'facility': 'William B Farquhar', 'geoPoint': {'lat': 39.68372, 'lon': -75.74966}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Delaware', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}, {'name': 'National Institute of General Medical Sciences (NIGMS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}