Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2026-03-04 @ 4:43 AM
Study NCT ID:
NCT01727518
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-12-17
First Post:
2012-11-04
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Austrian LEAD (Lung hEart sociAl boDy) Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'C564221', 'term': 'Glucocorticoid Receptor Deficiency'}], 'ancestors': [{'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Robab.Breyer-Kohansal@lunghealth.lbg.ac.at', 'phone': '+436505398439', 'title': 'Dr Robab Breyer-Kohansal', 'organization': 'Ludwig Boltzmann Institute for Lung Health'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'As the LEAD study is an observational cohort study, there is no intervention, and therefore, "All-Cause Mortality", "Serious Adverse Events", and "Other (Not Including Serious) Adverse Events" were not monitored/assessed.', 'description': 'As the LEAD study is an observational cohort study, there is no intervention, and therefore, "All-Cause Mortality", "Serious Adverse Events", and "Other (Not Including Serious) Adverse Events" were not monitored/assessed.', 'eventGroups': [{'id': 'EG000', 'title': 'General Population', 'description': 'As the LEAD study is an observational cohort study, there is no intervention, and therefore no adverse effects are assessed or monitored.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Abnormal Lung Function in the General Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '981', 'groupId': 'OG000'}, {'value': '2012', 'groupId': 'OG001'}, {'value': '2404', 'groupId': 'OG002'}, {'value': '3010', 'groupId': 'OG003'}, {'value': '2972', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'General Population (6-15 Years)', 'description': 'participants at age category of 6-\\<15 years'}, {'id': 'OG001', 'title': 'General Population (15-30 Years)', 'description': 'participants at age category of 15-\\<30 years'}, {'id': 'OG002', 'title': 'General Population (30-45 Years)', 'description': 'participants at age category of 30-\\<45 years'}, {'id': 'OG003', 'title': 'General Population (45-60 Years)', 'description': 'participants at age category of 45-\\<60 years'}, {'id': 'OG004', 'title': 'General Population (60-82 Years)', 'description': 'participants at age category of 60-82 years'}], 'classes': [{'title': 'percentage of participants with FEV1< lower limit of normal (LLN)', 'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}, {'value': '178', 'groupId': 'OG002'}, {'value': '226', 'groupId': 'OG003'}, {'value': '252', 'groupId': 'OG004'}]}]}, {'title': 'percentage of participants with FVC< lower limit of normal (LLN)', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}, {'value': '96', 'groupId': 'OG002'}, {'value': '108', 'groupId': 'OG003'}, {'value': '143', 'groupId': 'OG004'}]}]}, {'title': 'percentage of participants with FEV1/FVC< lower limit of normal (LLN)', 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}, {'value': '211', 'groupId': 'OG002'}, {'value': '259', 'groupId': 'OG003'}, {'value': '235', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 years', 'description': 'Prebronchodilation (pre-BD) and post-BD forced spirometry measurements were determined according to international recommendations (ERS Global Lung Function Initiative). Abnromal lung function determined as forced expiratory volume in 1 second (FEV1) \\< Lower Limit of Normal (LLN) or forced vital capacity (FVC) \\< LLN or FEV1/FVC \\< LLN.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'General population cohort'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'General Population', 'description': 'Due to the observational, non interventional design of this study, there is only one Arm/Group (general population).\n\nAll participants of the study receive the same measurements and quetionnaires and are re-evaluated every 4 years.\n\nMeasurements include 1. lung function testing (spirometry/bodyplethysmography pre and post BD), 2. body composition testing (DXA Scan), 3. cardiovadcular testing (pulse wave velocity, ecg), 4. Skin Prick Test. For more detailed information please see study profile.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14966'}]}, {'type': 'COMPLETED', 'comment': 'Ongoing longitudinal study', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14966'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14966', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Reference Population', 'description': 'No Intervention; obersvation healthy group (no symptoms and no lung function impairment)'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '3182', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '9652', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '2132', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8006', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '6960', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Austria', 'categories': [{'measurements': [{'value': '14966', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Samples of urine and blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14966}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2028-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-21', 'studyFirstSubmitDate': '2012-11-04', 'resultsFirstSubmitDate': '2020-04-13', 'studyFirstSubmitQcDate': '2012-11-15', 'lastUpdatePostDateStruct': {'date': '2024-12-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-09-23', 'studyFirstPostDateStruct': {'date': '2012-11-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-11-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Abnormal Lung Function in the General Population', 'timeFrame': '4 years', 'description': 'Prebronchodilation (pre-BD) and post-BD forced spirometry measurements were determined according to international recommendations (ERS Global Lung Function Initiative). Abnromal lung function determined as forced expiratory volume in 1 second (FEV1) \\< Lower Limit of Normal (LLN) or forced vital capacity (FVC) \\< LLN or FEV1/FVC \\< LLN.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['natural history', 'lung function', 'general population', 'metabolic health'], 'conditions': ['Respiration Disorders', 'Body Composition, Beneficial', 'Metabolic Health']}, 'referencesModule': {'references': [{'pmid': '40309217', 'type': 'DERIVED', 'citation': 'Dal Grande A, Van Herck M, Breyer-Kohansal R, Mraz T, Karimi A, Azizzadeh M, Hartl S, Burghuber OC, Wouters EFM, Kautzky-Willer A, Schiffers C, Breyer MK. Incidence of Prediabetes and Diabetes in a European Longitudinal General Population Cohort and Its Associated Factors-Results From the Austrian LEAD Study. J Diabetes Res. 2025 Apr 22;2025:5540276. doi: 10.1155/jdr/5540276. eCollection 2025.'}, {'pmid': '35431559', 'type': 'DERIVED', 'citation': 'Kolli F, Breyer MK, Hartl S, Burghuber O, Wouters EFM, Sigsgaard T, Pohl W, Kohlbock G, Breyer-Kohansal R. Aero-Allergen Sensitization in the General Population: Longitudinal Analyses of the LEAD (Lung Heart Social Body) Study. J Asthma Allergy. 2022 Apr 11;15:461-473. doi: 10.2147/JAA.S349614. eCollection 2022.'}, {'pmid': '30344197', 'type': 'DERIVED', 'citation': 'Breyer-Kohansal R, Hartl S, Burghuber OC, Urban M, Schrott A, Agusti A, Sigsgaard T, Vogelmeier C, Wouters E, Studnicka M, Breyer MK. The LEAD (Lung, Heart, Social, Body) Study: Objectives, Methodology, and External Validity of the Population-Based Cohort Study. J Epidemiol. 2019 Aug 5;29(8):315-324. doi: 10.2188/jea.JE20180039. Epub 2018 Oct 20.'}], 'seeAlsoLinks': [{'url': 'http://www.leadstudy.at', 'label': 'Homepage of the Austrian LEAD Study for participants and researchers'}, {'url': 'https://www.jstage.jst.go.jp/article/jea/advpub/0/advpub_JE20180039/_pdf/-char/en', 'label': 'Link to the Study profile; published in 2019'}, {'url': 'http://lunghealth.lbg.ac.at/?lang=en', 'label': 'Homepage of Ludwig Bultzmann Institute for lung health'}]}, 'descriptionModule': {'briefSummary': 'The LEAD study is the first longitudinal cohort investigating respiratory, cardiac, and metabolic health in a reference population of Austria.', 'detailedDescription': 'The LEAD (Lung, hEart, sociAl, boDy) study is a longitudinal, observational, population-based cohort study aimed at investigating the prevalence and incidence of health disorders and the relationships between social, environmental, developmental, and aging factors that influence respiratory, cardiac, and metabolic health and comorbidities throughout life.\n\nA random sample (male and female, age 6 - 80 years) of Vienna inhabitants (urban cohort) and all the inhabitants of six villages from Lower Austria (rural cohort) were invited to participate. Participants are followed up every four years. A number of investigations and measurements are obtained in each of the four domains of the study (Lung, hEart, sociAl, boDy), as briefly discussed below.\n\nLung Domain: Lung function measures include pre- and post-bronchodilation spirometry and static lung volumes, effort-independent measures of oscillatory resistance, and carbon monoxide lung diffusing capacity (DLCO). Measurements are obtained according to international recommendations, and reference values correspond to those of the Global Lung Function Initiative (GLI). Smoking history and exposure to environmental tobacco smoke (ETS) are recorded. History of respiratory diseases, allergies, and related medications from the individual and spouses, as well as respiratory symptoms, are collected using a questionnaire.\n\nHeart Domain: Cardiovascular measurements include arterial blood pressure, automated electrocardiogram, carotid-femoral pulse wave velocity, and blood pressure measurements at both the upper and lower extremities. History of cardiovascular diseases and events, as well as related medications, are collected using a questionnaire.\n\nSocial Domain: Socioeconomic status (income, education, occupation) of the individual or parents/legal representative (if underage) is collected. To study the presence of neuropsychiatric diseases such as anxiety, depression, and impaired cognitive function, standardized questionnaires and test modules are used.\n\nBody Domain: To determine the presence of diabetes and metabolic syndrome, we measure fasting glucose in peripheral venous blood, glycated hemoglobin (HbA1c), body mass index, waist circumference, fat mass, fat-free mass, blood lipid profiles, and blood pressure. The presence of osteoporosis is determined using dual-energy X-ray absorptiometry. History of diabetes, metabolic syndrome, and osteoporosis, as well as related medications from the individual, are collected using a questionnaire.\n\nBlood and urine samples are analyzed for routine clinical measurements and stored in a biobank for future investigations.\n\nAll measurements are performed at the LEAD study center of the Ludwig Boltzmann Institute for Lung Health at the Otto Wagner Hospital in Vienna, Austria.\n\nThis health examination will be the first investigation in Austria providing information about the respiratory, cardiovascular, and metabolic health and relevant comorbidities in a longitudinal approach.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '6 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Community based cohort', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and Female,\n* Age 6 - 80 years,\n* Invitation by study invitation letter\n\nExclusion Criteria:\n\n* Insufficient language skills\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT01727518', 'acronym': 'LEAD', 'briefTitle': 'The Austrian LEAD (Lung hEart sociAl boDy) Study', 'organization': {'class': 'OTHER', 'fullName': 'Ludwig Boltzmann Institute for Lung Health'}, 'officialTitle': 'The Austrian LEAD (Lung hEart sociAl boDy) Study', 'orgStudyIdInfo': {'id': 'LEAD1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Reference Population', 'description': 'No Intervention', 'interventionNames': ['Other: As the LEAD study is an observational cohort study, there is no intervention to report.']}], 'interventions': [{'name': 'As the LEAD study is an observational cohort study, there is no intervention to report.', 'type': 'OTHER', 'description': 'As the LEAD study is an observational cohort study, there is no intervention to report.', 'armGroupLabels': ['Reference Population']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1140', 'city': 'Vienna', 'country': 'Austria', 'facility': 'The LEAD Study Center', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'overallOfficials': [{'name': 'Robab Breyer-Kohansal, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ludwig Boltzmann Institute for Lung Health, Vienna, Austria'}, {'name': 'Marie-Kathrin Breyer, Prof. Dr', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ludwig Boltzmann Institute for Lung Health, Vienna, Austria'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ludwig Boltzmann Institute for Lung Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}