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The LEAD study is the first longitudinal cohort investigating respiratory, cardiac, and metabolic health in a reference population of Austria.
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.
A 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.
Lung 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.
Heart 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.
Social 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.
Body 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.
Blood and urine samples are analyzed for routine clinical measurements and stored in a biobank for future investigations.
All measurements are performed at the LEAD study center of the Ludwig Boltzmann Institute for Lung Health at the Otto Wagner Hospital in Vienna, Austria.
This 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reference Population | No Intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| As the LEAD study is an observational cohort study, there is no intervention to report. | Other | As the LEAD study is an observational cohort study, there is no intervention to report. |
| Measure | Description | Time Frame |
|---|---|---|
| Abnormal Lung Function in the General Population | 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. | 4 years |
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Inclusion Criteria:
Exclusion Criteria:
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Community based cohort
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| Name | Affiliation | Role |
|---|---|---|
| Robab Breyer-Kohansal, Prof. Dr. | Ludwig Boltzmann Institute for Lung Health, Vienna, Austria | Principal Investigator |
| Marie-Kathrin Breyer, Prof. Dr | Ludwig Boltzmann Institute for Lung Health, Vienna, Austria | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The LEAD Study Center | Vienna | 1140 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41537373 | Derived | Azizzadeh M, Karimi A, Danninger K, Breyer MK, Breyer-Kohansal R, Konig A, Kaufmann CC, Boutouyrie P, Bruno RM, Mayer CC, Jager B, Hartl S, Burghuber OC, Weber T. Prevalence and determinants of vascular aging in Austria - a holistic view: the LEAD study. J Hypertens. 2026 Mar 1;44(3):489-497. doi: 10.1097/HJH.0000000000004227. Epub 2026 Jan 12. | |
| 41456725 |
| Label | URL |
|---|---|
| Homepage of the Austrian LEAD Study for participants and researchers | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | General Population | Due to the observational, non interventional design of this study, there is only one Arm/Group (general population). All participants of the study receive the same measurements and quetionnaires and are re-evaluated every 4 years. Measurements 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Reference Population | No Intervention; obersvation healthy group (no symptoms and no lung function impairment) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Abnormal Lung Function in the General Population | 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. | General population cohort | Posted | Count of Participants | Participants | 4 years |
|
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.
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | General Population | As the LEAD study is an observational cohort study, there is no intervention, and therefore no adverse effects are assessed or monitored. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Robab Breyer-Kohansal | Ludwig Boltzmann Institute for Lung Health | +436505398439 | Robab.Breyer-Kohansal@lunghealth.lbg.ac.at |
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| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| C564221 | Glucocorticoid Receptor Deficiency |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
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Samples of urine and blood
| Ofenheimer A, Wouters EFM, Gross C, Helk O, Mraz T, Azizzadeh M, Hartl S, Breyer-Kohansal R, Breyer MK. Relationship of body composition and lung function in adult and elderly males and females. Respir Med. 2026 Feb;252:108610. doi: 10.1016/j.rmed.2025.108610. Epub 2025 Dec 26. |
| 40309217 | Derived | 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. |
| 35431559 | Derived | 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. |
| 30344197 | Derived | 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. |
| Link to the Study profile; published in 2019 | View source |
| Homepage of Ludwig Bultzmann Institute for lung health | View source |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | General Population (30-45 Years) | participants at age category of 30-<45 years |
| OG003 | General Population (45-60 Years) | participants at age category of 45-<60 years |
| OG004 | General Population (60-82 Years) | participants at age category of 60-82 years |
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