Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2026-01-05 @ 5:59 PM
Study NCT ID:
NCT02821104
Status:
COMPLETED
Last Update Posted:
2021-06-11
First Post:
2016-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Complement and Cardiovascular Risk in Adolescents
Sponsor:
Organization:
Raw JSON
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Hospi"}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '4 hours', 'eventGroups': [{'id': 'EG000', 'title': 'Healthy Adolescents', 'description': 'Healthy non-Hispanic white adolescents between 12 and 18 years of age', 'otherNumAtRisk': 75, 'deathsNumAtRisk': 75, 'otherNumAffected': 0, 'seriousNumAtRisk': 75, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Complement C3 Genotype', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Adolescents', 'description': 'Non Hispanic white'}], 'classes': [{'categories': [{'title': 'FS', 'measurements': [{'value': '22', 'groupId': 'OG000'}]}, {'title': 'SS', 'measurements': [{'value': '45', 'groupId': 'OG000'}]}, {'title': 'FF', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'missing', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline', 'description': 'Genetic C3F genotype allele presence', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Total population'}, {'type': 'PRIMARY', 'title': 'C4 Copy Number', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Adolescents', 'description': 'Healthy non-Hispanic white adolescents between 12 and 18 years'}], 'classes': [{'title': 'C4A Copy number', 'categories': [{'title': '1', 'measurements': [{'value': '14', 'groupId': 'OG000'}]}, {'title': '2', 'measurements': [{'value': '35', 'groupId': 'OG000'}]}, {'title': '3', 'measurements': [{'value': '15', 'groupId': 'OG000'}]}, {'title': '4', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'missing', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': '0', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'C4B copy number', 'categories': [{'title': '1', 'measurements': [{'value': '20', 'groupId': 'OG000'}]}, {'title': '2', 'measurements': [{'value': '45', 'groupId': 'OG000'}]}, {'title': '3', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': '4', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'missing', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': '0', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline', 'description': 'C4A or C4B gene copy numbers', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'BMI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Adolescents', 'description': 'Healthy non Hispanic white adolescents'}], 'classes': [{'categories': [{'measurements': [{'value': '22.0', 'spread': '0.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Body mass index', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Waist Circumference', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Adolescents', 'description': 'Healthy non-Hispanic white adolescents between 12 and 18 years of age'}], 'classes': [{'categories': [{'measurements': [{'value': '72.5', 'spread': '1.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Waist circumference at narrowest point', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Body Fat', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Adolescents', 'description': 'Healthy non-Hispanic white adolescents between 12 and 18 years of age'}], 'classes': [{'categories': [{'measurements': [{'value': '23.9', 'spread': '1.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Percent body fat BodPod', 'unitOfMeasure': 'percentage of total body weight', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Endothelial Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Adolescents', 'description': 'Healthy non-Hispanic white adolescents between 12 and 18 years of age'}], 'classes': [{'categories': [{'measurements': [{'value': '-81.7', 'spread': '0.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 min', 'description': 'reactive hyperemia response to upper arm occlusion', 'unitOfMeasure': 'percentage change from baseline FVR', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Vascular Stiffness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Adolescents', 'description': 'Healthy non-Hispanic white adolescents between 12 and 18 years of age'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.3', 'spread': '2.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline', 'description': 'augmentation index of reflected blood pressure wave', 'unitOfMeasure': 'percentage of peak blood pressure', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Endothelin 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Adolescents', 'description': 'Healthy non-Hispanic white adolescents between 12 and 18 years of age'}], 'classes': [{'categories': [{'measurements': [{'value': '2.06', 'spread': '0.06', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Inflammation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Adolescents', 'description': 'Healthy non-Hispanic white adolescents between 12 and 18 years of age'}], 'classes': [{'categories': [{'measurements': [{'value': '0.68', 'spread': '0.08', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline', 'description': 'IL6', 'unitOfMeasure': 'mg/ml', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Clotting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Adolescents', 'description': 'Healthy non-Hispanic white adolescents between 12 and 18 years of age'}], 'classes': [{'categories': [{'measurements': [{'value': '3.78', 'spread': '0.32', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline', 'description': 'PAI1', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Insulin Sensitivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Adolescents', 'description': 'Healthy non-Hispanic white adolescents between 12 and 18 years of age'}], 'classes': [{'categories': [{'measurements': [{'value': '4.25', 'spread': '0.27', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline', 'description': 'Oral glucose tolerance test', 'unitOfMeasure': 'units', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Healthy Adolescents', 'description': 'Healthy non-Hispanic white adolescents between 12 and 18 years of age'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '77'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '77'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Healthy Adolescents', 'description': 'Healthy non-Hispanic white adolescents between 12 and 18 years'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '15.2', 'spread': '1.67', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '34', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '41', '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': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '75', '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': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '22.0', 'spread': '5.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Non-Hispanic, healthy White adolescents'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-11-05', 'size': 313636, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-11-05T13:40', 'hasProtocol': True}, {'date': '2016-12-06', 'size': 287566, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-11-05T13:42', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 77}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2018-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-14', 'studyFirstSubmitDate': '2016-06-29', 'resultsFirstSubmitDate': '2020-09-21', 'studyFirstSubmitQcDate': '2016-06-30', 'lastUpdatePostDateStruct': {'date': '2021-06-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-05-14', 'studyFirstPostDateStruct': {'date': '2016-07-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complement C3 Genotype', 'timeFrame': 'Baseline', 'description': 'Genetic C3F genotype allele presence'}, {'measure': 'C4 Copy Number', 'timeFrame': 'Baseline', 'description': 'C4A or C4B gene copy numbers'}], 'secondaryOutcomes': [{'measure': 'BMI', 'timeFrame': 'Baseline', 'description': 'Body mass index'}, {'measure': 'Waist Circumference', 'timeFrame': 'Baseline', 'description': 'Waist circumference at narrowest point'}, {'measure': 'Body Fat', 'timeFrame': 'Baseline', 'description': 'Percent body fat BodPod'}, {'measure': 'Endothelial Function', 'timeFrame': '8 min', 'description': 'reactive hyperemia response to upper arm occlusion'}, {'measure': 'Vascular Stiffness', 'timeFrame': 'baseline', 'description': 'augmentation index of reflected blood pressure wave'}, {'measure': 'Endothelin 1', 'timeFrame': 'baseline'}, {'measure': 'Inflammation', 'timeFrame': 'baseline', 'description': 'IL6'}, {'measure': 'Clotting', 'timeFrame': 'baseline', 'description': 'PAI1'}, {'measure': 'Insulin Sensitivity', 'timeFrame': 'baseline', 'description': 'Oral glucose tolerance test'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Complement', 'endothelial function', 'insulin sensitivity', 'adolescents', 'inflammation'], 'conditions': ['Cardiovascular Disease', 'Type 2 Diabetes']}, 'referencesModule': {'references': [{'pmid': '33818037', 'type': 'DERIVED', 'citation': 'Hoffman RP, Copenhaver MM, Zhou D, Yu CY. Oral glucose tolerance response curve predicts disposition index but not other cardiometabolic risk factors in healthy adolescents. J Pediatr Endocrinol Metab. 2021 Apr 5;34(5):599-605. doi: 10.1515/jpem-2020-0619. Print 2021 May 26.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates how genetic variations in complement, a part of the immune system, affect cardiovascular risk in adolescents.', 'detailedDescription': 'Cardiometabolic diseases usually do not produce significant mortality and morbidity until adulthood. There is clear evidence, however, that these diseases have their origins in childhood and adolescence. With the rising incidence of obesity associated with poorer eating and less physical activity in children and adolescents it is important that the investigators study these diseases early in their course if the investigators are to prevent future cardiometabolic disease. While obesity clearly increases cardiometabolic risk, not all obese subjects are at increased risk; approximately 25-30% of obese adults and adolescents are metabolically healthy. The complement system is key physiological component in controlling inflammation and recent studies have indicated complement plays an important role in increasing obesity and cardiometabolic risk. Adults with proven cardiometabolic disease or at future risk for cardiometabolic disease have increased levels of the complement components C3, C3a-desArg, and C4 compared to healthy, not at risk, control subjects, independent of obesity. Increased C3 or C3a-desArg levels in adolescents are associated with increased cardiometabolic risk independent of obesity. Two specific single nucleotide polymorphisms (SNPs) in the intron for C3, rs11569562 and rs2250656, both with A\\>G polymorphisms, are associated with increased serum C3 levels, and increases in a variety of cardiovascular risk factors. No one has investigated how C3 polymorphisms affect risk factors in adolescents. The C4 gene has significant copy number variation and increased copy number is associated with increased C4 levels. The relationship of C4 gene copy number to cardiometabolic risk has not been studied in adults or adolescents. The short-term objectives of this study are to explore differences in cardiometabolic risk factors in overweight and obese adolescents with C3 polymorphisms and also to explore how C4 gene copy number variation affects risk factors. The investigators overall hypothesis is that variations in C3 polymorphisms, C4 gene copy number or both will have significant impact on cardiometabolic health in overweight and obese adolescents. Both traditional and nontraditional cardiometabolic risk markers, including measures of body habitus, blood pressure, lipids, vascular function, insulin secretion and sensitivity, inflammation, and clotting will be investigated in 100 overweight and obese adolescents. The investigators proposed study will help us understand the role of complement and its genetics in the development of cardiometabolic risk and in potentially developing genetic biomarkers for adolescents at increased risk.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '12 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy adolescents', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adolescents age 12 to 18 years\n* Medication free for 2 weeks except oral contraceptives in females\n* Non Hispanic white\n\nExclusion Criteria:\n\n* Chronic medications except for contraceptives in females.\n* History of autoimmune disease either endocrine or connective tissue type\n* History of hematologic or renal disease, malignancy or other chronic disease\n* Hispanic ethnicity,\n* African-American or Asian race'}, 'identificationModule': {'nctId': 'NCT02821104', 'acronym': 'CCRIA', 'briefTitle': 'Complement and Cardiovascular Risk in Adolescents', 'organization': {'class': 'OTHER', 'fullName': 'Ohio State University'}, 'officialTitle': 'Complement and Cardiovascular Risk in Adolescents', 'orgStudyIdInfo': {'id': 'Peds34'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy Adolescents', 'description': 'Healthy non Hispanic white adolescents'}]}, 'contactsLocationsModule': {'locations': [{'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Clinical Trials.gov'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ohio State University', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Heart Association', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Robert Hoffman', 'investigatorAffiliation': 'Ohio State University'}}}}