Ignite Creation Date:
2025-12-24 @ 12:41 PM
Ignite Modification Date:
2025-12-27 @ 9:20 PM
Study NCT ID:
NCT04195061
Status:
COMPLETED
Last Update Posted:
2024-01-30
First Post:
2019-12-09
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Relative Sarcopenia and Cardiometabolic Risk in Young Adults With Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005080', 'term': 'Exercise Test'}], 'ancestors': [{'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D012129', 'term': 'Respiratory Function Tests'}, {'id': 'D003948', 'term': 'Diagnostic Techniques, Respiratory System'}, {'id': 'D016552', 'term': 'Ergometry'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mshaines@mgh.harvard.edu', 'phone': '617-726-3870', 'title': 'Melanie S. Haines, MD', 'organization': 'Massachusetts General Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 week', 'eventGroups': [{'id': 'EG000', 'title': 'Insulin Sensitive', 'description': 'Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) \\<1.9', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 0, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Insulin Resistant', 'description': 'Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) \\>/= 1.9', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 1, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Change in Serum Myostatin Levels From Pre- to 3 Hours Post-exercise', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Sensitive', 'description': 'Homeostatic Model Assessment for Insulin Resistance \\< 1.9'}, {'id': 'OG001', 'title': 'Insulin Resistant', 'description': 'Homeostatic Model Assessment for Insulin Resistance \\>/= 1.9'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.9', 'spread': '41.8', 'groupId': 'OG000'}, {'value': '8.5', 'spread': '27.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.303', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Pre- to 3 hours post-exercise', 'description': 'Percent change in serum myostatin levels from pre- to 3 hours post-cardiopulmonary exercise test', 'unitOfMeasure': '% change in serum myostatin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Four participants excluded from this analysis due to metformin use (n=2), testosterone use (n=1) or incomplete laboratory data (n=1).'}, {'type': 'SECONDARY', 'title': 'Percent Change in Serum Myostatin Levels From Pre- to 2 Hours Post-exercise', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Sensitive', 'description': 'Homeostatic Model Assessment for Insulin Resistance \\< 1.9'}, {'id': 'OG001', 'title': 'Insulin Resistant', 'description': 'Homeostatic Model Assessment for Insulin Resistance \\>/= 1.9'}], 'classes': [{'categories': [{'measurements': [{'value': '-9.7', 'spread': '39.4', 'groupId': 'OG000'}, {'value': '21.7', 'spread': '26.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.035', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Pre- to 2 hours post-exercise', 'description': 'Percent change in serum myostatin levels from pre- to 2 hours post-cardiopulmonary exercise test', 'unitOfMeasure': '% change in serum myostatin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Four participants excluded from the analysis due to metformin use (n=2), testosterone use (n=1), or incomplete laboratory data (n=1).'}, {'type': 'SECONDARY', 'title': 'Percent Change in Serum Myostatin Levels From Immediately Post to 2 Hours Post-exercise', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Sensitive', 'description': 'Homeostatic Model Assessment for Insulin Resistance \\< 1.9'}, {'id': 'OG001', 'title': 'Insulin Resistant', 'description': 'Homeostatic Model Assessment for Insulin Resistance \\>/= 1.9'}], 'classes': [{'categories': [{'measurements': [{'value': '-20.3', 'spread': '36.0', 'groupId': 'OG000'}, {'value': '13.5', 'spread': '18.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.007', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Immediately post to 2 hours post-exercise', 'description': 'Percent change in serum myostatin levels from immediately post to 2 hours post-cardiopulmonary exercise test', 'unitOfMeasure': '% change in serum myostatin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Four participants excluded from the analysis due to metformin use (n=2), testosterone use (n=1), or incomplete laboratory data (n=1)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Insulin Sensitive', 'description': 'Homeostatic model assessment for insulin resistance (HOMA-IR) \\<1.9'}, {'id': 'FG001', 'title': 'Insulin Resistant', 'description': 'Homeostatic model assessment for insulin resistance (HOMA-IR) \\>/=1.9'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Insulin Sensitive', 'description': 'Homeostatic model assessment for insulin resistance (HOMA-IR) \\<1.9'}, {'id': 'BG001', 'title': 'Insulin Resistant', 'description': 'Homeostatic model assessment for insulin resistance (HOMA-IR) \\>/=1.9'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.0', 'spread': '13.2', 'groupId': 'BG000'}, {'value': '50.0', 'spread': '12.0', 'groupId': 'BG001'}, {'value': '53.4', 'spread': '12.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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': '2', 'groupId': 'BG000'}, {'value': '0', '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': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Fasting serum myostatin', 'classes': [{'categories': [{'measurements': [{'value': '9.84', 'spread': '3.19', 'groupId': 'BG000'}, {'value': '9.16', 'spread': '2.34', 'groupId': 'BG001'}, {'value': '9.62', 'spread': '2.92', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body mass index', 'classes': [{'categories': [{'measurements': [{'value': '30.2', 'spread': '4.0', 'groupId': 'BG000'}, {'value': '40.8', 'spread': '8.8', 'groupId': 'BG001'}, {'value': '33.6', 'spread': '7.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-06-14', 'size': 363429, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-02-07T23:07', 'hasProtocol': True}, {'date': '2021-06-14', 'size': 30978, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-02-07T23:07', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2021-11-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-19', 'studyFirstSubmitDate': '2019-12-09', 'resultsFirstSubmitDate': '2023-02-07', 'studyFirstSubmitQcDate': '2019-12-09', 'lastUpdatePostDateStruct': {'date': '2024-01-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-01-19', 'studyFirstPostDateStruct': {'date': '2019-12-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change in Serum Myostatin Levels From Pre- to 3 Hours Post-exercise', 'timeFrame': 'Pre- to 3 hours post-exercise', 'description': 'Percent change in serum myostatin levels from pre- to 3 hours post-cardiopulmonary exercise test'}], 'secondaryOutcomes': [{'measure': 'Percent Change in Serum Myostatin Levels From Pre- to 2 Hours Post-exercise', 'timeFrame': 'Pre- to 2 hours post-exercise', 'description': 'Percent change in serum myostatin levels from pre- to 2 hours post-cardiopulmonary exercise test'}, {'measure': 'Percent Change in Serum Myostatin Levels From Immediately Post to 2 Hours Post-exercise', 'timeFrame': 'Immediately post to 2 hours post-exercise', 'description': 'Percent change in serum myostatin levels from immediately post to 2 hours post-cardiopulmonary exercise test'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Overweight and Obesity', 'Insulin Resistance']}, 'descriptionModule': {'briefSummary': 'The goal of this research study is to learn more about the hormones that muscles make during exercise, and if those hormones are associated with type 2 diabetes risk in adults who are overweight or obese. Participants will undergo exercise testing on an upright bicycle, with blood samples taken for muscle hormones before and after exercise. The hypothesis is that adults with overweight/obesity and insulin resistance will have an impaired muscle hormone profile in response to exercise compared to adults with overweight/obesity who are not insulin resistant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults with overweight or obesity', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Previously enrolled in protocol 2004P000013 or protocol 2012P002276, which had overweight or obesity as inclusion criteria\n* Ability to walk up 3 flights of stairs and 3 city blocks (to ensure ability to complete exercise testing)\n\nExclusion Criteria:\n\n* Unstable heart or lung disease\n* Exercise \\>150 minutes/week\n* Participation in college sports'}, 'identificationModule': {'nctId': 'NCT04195061', 'briefTitle': 'Relative Sarcopenia and Cardiometabolic Risk in Young Adults With Obesity', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Relative Sarcopenia and Cardiometabolic Risk in Young Adults With Obesity', 'orgStudyIdInfo': {'id': '2017P001495'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cardiopulmonary exercise testing', 'interventionNames': ['Procedure: Cardiopulmonary exercise test (CPET)']}], 'interventions': [{'name': 'Cardiopulmonary exercise test (CPET)', 'type': 'PROCEDURE', 'description': 'CPET studies will be performed in the Cardiovascular Performance Program exercise lab at MGH. Subjects will undergo CPET on an upright cycle ergometer with continual measurement of metabolic gas exchange via a commercially available metabolic cart as well as heart rate and blood pressure. Exercise will proceed according to a maximal effort clinical protocol. Subjects will then undergo a standardized 30-min work load on the upright cycle ergometer based on the results of the maximal effort clinical protocol.', 'armGroupLabels': ['Cardiopulmonary exercise testing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Melanie S Haines, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Melanie Schorr Haines, M.D', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}