Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-27 @ 11:03 PM
Study NCT ID:
NCT01816893
Status:
COMPLETED
Last Update Posted:
2018-04-02
First Post:
2013-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Hypoglycemia and Autonomic Nervous System Function
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007003', 'term': 'Hypoglycemia'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'gadler@bwh.harvard.edu', 'phone': '(617) 732-8742', 'title': 'Dr. Gail Kurr Adler', 'organization': "Brigham and Women's Hospital"}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data was collected for about a week (during each 3-day assessment and for a few days afterwards).', 'eventGroups': [{'id': 'EG000', 'title': 'Euglycemic Clamp', 'description': 'Participant undergoes a euglycemic hyperinsulinemic clamp', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 0, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Hypoglycemic Clamp', 'description': 'Participant undergoes a hypoglycemic hyperinsulinemic clamp', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Baroreflex Sensitivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Euglycemic Clamp', 'description': 'participant undergoes a euglycemic hyperinsulinemic clamp\n\nEuglycemia'}, {'id': 'OG001', 'title': 'Hypoglycemic Clamp', 'description': 'participant undergoes a hypoglycemic hyperinsulinemic clamp\n\nHypoglycemia'}], 'classes': [{'categories': [{'measurements': [{'value': '2.3', 'spread': '6.3', 'groupId': 'OG000'}, {'value': '-1.6', 'spread': '4.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '16 hours after euglycemic and hypoglycemic clamps as compared to baseline', 'description': 'The change in baroreflex sensitivity (milliseconds/mm Hg) is calculated as baroreflex sensitivity (milliseconds/mm Hg) on day 3 \\[assessed 16 hours after the clamp\\] minus baroreflex sensitivity (milliseconds/mm Hg) on day 1 \\[baseline assessment on the day prior to the clamp\\]). Change in baroreflex sensitivity in euglycemic clamp arm is compared to change in baroreflex sensitivity in hypoglycemic arm.', 'unitOfMeasure': 'ms/mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '20 subjects completed both arms, but only 18 had the change in BRS outcome for both arms.'}, {'type': 'SECONDARY', 'title': 'Muscle Sympathetic Nerve Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Euglycemic Clamp', 'description': 'participant undergoes a euglycemic hyperinsulinemic clamp\n\nEuglycemia'}, {'id': 'OG001', 'title': 'Hypoglycemic Clamp', 'description': 'participant undergoes a hypoglycemic hyperinsulinemic clamp\n\nHypoglycemia'}], 'classes': [{'title': 'At rest', 'categories': [{'measurements': [{'value': '33.64', 'spread': '3.3', 'groupId': 'OG000'}, {'value': '26.4', 'spread': '4.8', 'groupId': 'OG001'}]}]}, {'title': 'With Nitroprusside', 'categories': [{'measurements': [{'value': '53.4', 'spread': '3.7', 'groupId': 'OG000'}, {'value': '40.1', 'spread': '2.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '16 hours after euglycemic and hypoglycemic clamps', 'description': 'Muscle sympathetic nerve activity (MSNA), at rest and immediately after nitroprusside, was measured on Day 3 about 16 hours after the euglycemic and hypoglycemic clamps.', 'unitOfMeasure': 'bursts/ minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '20 subjects completed both arms, but only 5 had the muscle sympathetic nerve activity outcome for both arms.'}, {'type': 'SECONDARY', 'title': 'Catecholamine Response to Lower-body Negative Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Euglycemic Clamp', 'description': 'participant undergoes a euglycemic hyperinsulinemic clamp\n\nEuglycemia'}, {'id': 'OG001', 'title': 'Hypoglycemic Clamp', 'description': 'participant undergoes a hypoglycemic hyperinsulinemic clamp\n\nHypoglycemia'}], 'classes': [{'categories': [{'measurements': [{'value': '3.0', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '0.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '16 hours after euglycemic and hypoglycemic clamps', 'description': 'Plasma norepinephrine response to lower body negative pressure (at the minus 40 mm Hg data point) on Day 3 about 16 to 20 hours after completion of the euglycemic or hypoglycemic clamp.', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 22 subjects who started the protocol, 20 completed both arms.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Euglycemic Clamp/ Washout Period/ Hypoglycemic Clamp', 'description': '1. Participant undergoes a euglycemic hyperinsulinemic clamp\n2. Participant undergoes a 1-3 month washout period\n3. Participant undergoes a hypoglycemic hyperinsulinemic clamp'}, {'id': 'FG001', 'title': 'Hypoglycemic Clamp/ Washout Period/ Euglycemic Clamp', 'description': '1. Participant undergoes a hypoglycemic hyperinsulinemic clamp\n2. Participant undergoes a 1-3 month washout period\n3. Participant undergoes a euglycemic hyperinsulinemic clamp'}], 'periods': [{'title': 'Euglycemic Clamp/ Hypoglycemic Clamp', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Washout Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Hypoglycemic Clamp/ Euglycemic Clamp', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Euglycemic Clamp/ Washout Period/ Hypoglycemic Clamp', 'description': '1. Participant undergoes a euglycemic hyperinsulinemic clamp\n2. Participant undergoes a 1-3 month washout period\n3. Participant undergoes a hypoglycemic hyperinsulinemic clamp'}, {'id': 'BG001', 'title': 'Hypoglycemic Clamp/ Washout Period/ Euglycemic Clamp', 'description': '1. Participant undergoes a hypoglycemic hyperinsulinemic clamp\n2. Participant undergoes a 1-3 month washout period\n3. Participant undergoes a euglycemic hyperinsulinemic clamp'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '28', 'spread': '6', 'groupId': 'BG000'}, {'value': '29', 'spread': '8', 'groupId': 'BG001'}, {'value': '28', 'spread': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-06-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2007-11-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-07', 'studyFirstSubmitDate': '2013-03-20', 'resultsFirstSubmitDate': '2018-01-30', 'studyFirstSubmitQcDate': '2013-03-20', 'lastUpdatePostDateStruct': {'date': '2018-04-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-01-30', 'studyFirstPostDateStruct': {'date': '2013-03-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2007-11-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Baroreflex Sensitivity', 'timeFrame': '16 hours after euglycemic and hypoglycemic clamps as compared to baseline', 'description': 'The change in baroreflex sensitivity (milliseconds/mm Hg) is calculated as baroreflex sensitivity (milliseconds/mm Hg) on day 3 \\[assessed 16 hours after the clamp\\] minus baroreflex sensitivity (milliseconds/mm Hg) on day 1 \\[baseline assessment on the day prior to the clamp\\]). Change in baroreflex sensitivity in euglycemic clamp arm is compared to change in baroreflex sensitivity in hypoglycemic arm.'}], 'secondaryOutcomes': [{'measure': 'Muscle Sympathetic Nerve Activity', 'timeFrame': '16 hours after euglycemic and hypoglycemic clamps', 'description': 'Muscle sympathetic nerve activity (MSNA), at rest and immediately after nitroprusside, was measured on Day 3 about 16 hours after the euglycemic and hypoglycemic clamps.'}, {'measure': 'Catecholamine Response to Lower-body Negative Pressure', 'timeFrame': '16 hours after euglycemic and hypoglycemic clamps', 'description': 'Plasma norepinephrine response to lower body negative pressure (at the minus 40 mm Hg data point) on Day 3 about 16 to 20 hours after completion of the euglycemic or hypoglycemic clamp.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hypoglycemia', 'Autonomic Nervous System', 'baroreflex sensitivity', 'muscle sympathetic nerve activity', 'lower body negative pressure'], 'conditions': ['Hypoglycemia']}, 'referencesModule': {'references': [{'pmid': '18332163', 'type': 'RESULT', 'citation': 'Dotson S, Freeman R, Failing HJ, Adler GK. Hypoglycemia increases serum interleukin-6 levels in healthy men and women. Diabetes Care. 2008 Jun;31(6):1222-3. doi: 10.2337/dc07-2243. Epub 2008 Mar 10.'}, {'pmid': '19056608', 'type': 'RESULT', 'citation': 'Adler GK, Bonyhay I, Failing H, Waring E, Dotson S, Freeman R. Antecedent hypoglycemia impairs autonomic cardiovascular function: implications for rigorous glycemic control. Diabetes. 2009 Feb;58(2):360-6. doi: 10.2337/db08-1153. Epub 2008 Dec 3.'}, {'pmid': '22921261', 'type': 'RESULT', 'citation': 'Gibbons CH, Adler GK, Bonyhay I, Freeman R. Experimental hypoglycemia is a human model of stress-induced hyperalgesia. Pain. 2012 Nov;153(11):2204-2209. doi: 10.1016/j.pain.2012.06.030. Epub 2012 Aug 23.'}, {'pmid': '20950382', 'type': 'RESULT', 'citation': 'Adler GK, Bonyhay I, Curren V, Waring E, Freeman R. Hypoglycaemia increases aldosterone in a dose-dependent fashion. Diabet Med. 2010 Nov;27(11):1250-5. doi: 10.1111/j.1464-5491.2010.03087.x.'}]}, 'descriptionModule': {'briefSummary': 'The goals of this proposal are to determine the effects of hypoglycemia on the autonomic nervous system.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Healthy volunteers\n* Males and females age 18 to 50 years\n\nExclusion Criteria\n\n* Pregnancy\n* Lactation\n* Subjects who smoke or are on other forms of nicotine will be excluded\n* Clinically evident coronary artery, cerebrovascular, or peripheral vascular disease, or presence of systemic illness that might affect autonomic function. Such illnesses include diabetes mellitus, congestive heart failure, hypertension, renal, pulmonary, hepatic disease, anemia, malignancies, untreated thyroid disease, and alcoholism.\n* Current major depressive illness\n* Any individuals on oral, injected, inhaled or topical corticosteroids within the last year or oral contraceptives within the past 3 months will be excluded.\n* Use of medications other than thyroxine'}, 'identificationModule': {'nctId': 'NCT01816893', 'acronym': 'HypoANS', 'briefTitle': 'Hypoglycemia and Autonomic Nervous System Function', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': 'Hypoglycemia and Autonomic Nervous System Function', 'orgStudyIdInfo': {'id': '2004P001233'}, 'secondaryIdInfos': [{'id': 'R01DK063296', 'link': 'https://reporter.nih.gov/quickSearch/R01DK063296', 'type': 'NIH'}, {'id': 'M01RR002635', 'link': 'https://reporter.nih.gov/quickSearch/M01RR002635', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Euglycemic hyperinsulinemic clamp', 'description': 'participant undergoes a euglycemic hyperinsulinemic clamp', 'interventionNames': ['Other: Euglycemic hyperinsulinemic clamp']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Hypoglycemic hyperinsulinemic clamp', 'description': 'participant undergoes a hypoglycemic hyperinsulinemic clamp', 'interventionNames': ['Other: Hypoglycemic hyperinsulinemic clamp']}], 'interventions': [{'name': 'Hypoglycemic hyperinsulinemic clamp', 'type': 'OTHER', 'armGroupLabels': ['Hypoglycemic hyperinsulinemic clamp']}, {'name': 'Euglycemic hyperinsulinemic clamp', 'type': 'OTHER', 'armGroupLabels': ['Euglycemic hyperinsulinemic clamp']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Gail K Adler, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Brigham and Women's Hospital"}, {'name': 'Roy L Freeman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beth Israel Deaconess Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The data collected will comply with the NIH requirements for timely release and data sharing. Data will be shared in the form of publications and presentations in scientific forums. As the NIH has noted, the investigators reserve the right to keep the data restricted in order to perform the initial analyses for this grant proposal and will continue to use the data for further, but not prolonged, exclusive use. Of note, the sharing of this data will be limited by at least the following issues, some unique to this proposal and some not unique. Some of the data obtained in this study is defined to be sensitive in nature, which may restrict its ability to be shared. Data may only be shared with the approval of our IRB and is limited by HIPPA and any other regulations that may be promulgated during the course of this proposal.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'Beth Israel Deaconess Medical Center', 'class': 'OTHER'}, {'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}, {'name': 'National Center for Research Resources (NCRR)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Medicine', 'investigatorFullName': 'Gail Adler', 'investigatorAffiliation': "Brigham and Women's Hospital"}}}}