Respiration DisordersLEADNCT01727518
The Austrian LEAD (Lung hEart sociAl boDy) Study
An observational study of Respiration Disorders and Body Composition, Beneficial, run by Ludwig Boltzmann Institute for Lung Health at 1 site in Austria.
Trial summary
The LEAD study is the first longitudinal cohort investigating respiratory, cardiac, and metabolic health in a reference population of Austria. Read more about this study
- Who is it for?
- Ages 6 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiration Disorders, Body Composition, Beneficial, Metabolic Health
- How many people
- 14,966 participants
- Where
- 1 siteAustria
- Study dates
- Oct 2011to Oct 2028
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Community based cohort
Who may be able to join
- Male and Female,
- Age 6 - 80 years,
- Invitation by study invitation letter
Who cannot join
- Insufficient language skills
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
The LEAD study is the first longitudinal cohort investigating respiratory, cardiac, and metabolic health in a reference population of Austria.
Read the detailed description
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.
- Being tested
- As the LEAD study is an observational cohort study, there is no intervention to report.
- Keywords
- natural history, lung function, general population, metabolic health
- Medical subject headings
- Respiration Disorders, Glucocorticoid Receptor Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Reference Population | No Intervention Receives: Other: As the LEAD study is an observational cohort study, there is no intervention to report. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2012 (estimated)
- Study startOct 2011
- Primary completionOct 2016
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Respiration DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 14,966 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ludwig Boltzmann Institute for Lung Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robab Breyer-Kohansal, Prof. Dr., Principal investigator, Ludwig Boltzmann Institute for Lung Health, Vienna, AustriaMarie-Kathrin Breyer, Prof. Dr, Study director, Ludwig Boltzmann Institute for Lung Health, Vienna, Austria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01727518
- Sponsor's protocol ID
- LEAD1
- Acronym
- LEAD
- Status last verified
- Aug 2026
- First submitted
- 4 Nov 2012
- Last updated
- 17 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Geissler K, Azizzadeh M, Gross C, Benetka G, Prinz-Wohlgenannt M, Breyer-Kohansal R, Hartl S, Breyer MK. Prevalence and potential associations of the 2022 newly introduced monocyte value for diagnosis of chronic myelomonocytic leukemia in a general Austrian population. Wien Med Wochenschr. 2026 Jul 13. doi: 10.1007/s10354-026-01172-5. Online ahead of print.
PubMed 42440049Azizzadeh 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.
PubMed 41537373Ofenheimer 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.
PubMed 41456725Dal 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.
PubMed 40309217Kolli 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.
PubMed 35431559Breyer-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.
PubMed 30344197
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Austrian LEAD (Lung hEart sociAl boDy) Study
- ClinicalTrials.gov ID
- NCT01727518
- Acronym / sponsor ID
- LEAD / LEAD1
- Keywords
- natural history, lung function, general population, metabolic health
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 14,966 participants (actual)
- Lead sponsor
- Ludwig Boltzmann Institute for Lung HealthUniversity, hospital or other
- Study start
- Oct 2011 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2028 (estimated)
- First posted
- 16 Nov 2012 (estimated)
- Results
- Posted 21 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The LEAD study is the first longitudinal cohort investigating respiratory, cardiac, and metabolic health in a reference population of Austria.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Reference Population | – | Other: As the LEAD study is an observational cohort study, there is no intervention to report.No Intervention |
Who may qualify
- Ages
- 6 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Community based cohort
Key inclusion criteria (3 listed)
- Male and Female,
- Age 6 - 80 years,
- Invitation by study invitation letter
Key exclusion criteria (2 listed)
- Insufficient language skills
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| As the LEAD study is an observational cohort study, there is no intervention to report.As the LEAD study is an observational cohort study, there is no intervention to report. | Other | Reference Population |
Primary outcome
Abnormal Lung Function in the General Population
Time frame: 4 years
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42440049Geissler K, Azizzadeh M, Gross C, Benetka G, Prinz-Wohlgenannt M, Breyer-Kohansal R, Hartl S, Breyer MK. Prevalence and potential associations of the 2022 newly introduced monocyte value for diagnosis of chronic myelomonocytic leukemia in a general Austrian population. Wien Med Wochenschr. 2026 Jul 13. doi: 10.1007/s10354-026-01172-5. Online ahead of print.
- Derived from this study: PubMed 41537373Azizzadeh 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.
- Derived from this study: PubMed 41456725Ofenheimer 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.
- Derived from this study: PubMed 40309217Dal 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.
- Derived from this study: PubMed 35431559Kolli 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.
- Derived from this study: PubMed 30344197Breyer-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.
- Homepage of the Austrian LEAD Study for participants and researchersLink provided by the sponsor.
- Link to the Study profile; published in 2019Link provided by the sponsor.
- Homepage of Ludwig Bultzmann Institute for lung healthLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robab Breyer-Kohansal, Prof. Dr. principal investigator
Ludwig Boltzmann Institute for Lung Health, Vienna, Austria
Marie-Kathrin Breyer, Prof. Dr study director
Ludwig Boltzmann Institute for Lung Health, Vienna, Austria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiration Disorders and Body Composition, Beneficial, run by Ludwig Boltzmann Institute for Lung Health at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abnormal Lung Function in the General Population (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01727518, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.