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The Austrian LEAD (Lung hEart sociAl boDy) Study

The Austrian LEAD (Lung hEart sociAl boDy) Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01727518
Acronym
LEAD
Enrollment
14966
Registered
2012-11-16
Start date
2011-10-01
Completion date
2028-10-01
Last updated
2026-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Body Composition, Beneficial, Metabolic Health, Respiration Disorders

Keywords

natural history, lung function, general population, metabolic health

Brief summary

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.

Interventions

OTHERAs 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.

Sponsors

Ludwig Boltzmann Institute for Lung Health
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
6 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

* Male and Female, * Age 6 - 80 years, * Invitation by study invitation letter

Exclusion criteria

* Insufficient language skills * pregnancy

Design outcomes

Primary

MeasureTime frameDescription
Abnormal Lung Function in the General Population4 yearsPrebronchodilation (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.

Countries

Austria

Contacts

PRINCIPAL_INVESTIGATORRobab Breyer-Kohansal, Prof. Dr.

Ludwig Boltzmann Institute for Lung Health, Vienna, Austria

STUDY_DIRECTORMarie-Kathrin Breyer, Prof. Dr

Ludwig Boltzmann Institute for Lung Health, Vienna, Austria

Participant flow

Participants by arm

ArmCount
Reference Population
No Intervention; obersvation healthy group (no symptoms and no lung function impairment)
14,966
Total14,966

Baseline characteristics

CharacteristicReference Population
Age, Categorical
<=18 years
3182 Participants
Age, Categorical
>=65 years
2132 Participants
Age, Categorical
Between 18 and 65 years
9652 Participants
Region of Enrollment
Austria
14966 participants
Sex: Female, Male
Female
8006 Participants
Sex: Female, Male
Male
6960 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 0
other
Total, other adverse events
0 / 0
serious
Total, serious adverse events
0 / 0

Outcome results

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.

Time frame: 4 years

Population: General population cohort

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
General Population (6-15 Years)Abnormal Lung Function in the General Populationpercentage of participants with FVC< lower limit of normal (LLN)52 Participants
General Population (6-15 Years)Abnormal Lung Function in the General Populationpercentage of participants with FEV1< lower limit of normal (LLN)65 Participants
General Population (6-15 Years)Abnormal Lung Function in the General Populationpercentage of participants with FEV1/FVC< lower limit of normal (LLN)44 Participants
General Population (15-30 Years)Abnormal Lung Function in the General Populationpercentage of participants with FVC< lower limit of normal (LLN)121 Participants
General Population (15-30 Years)Abnormal Lung Function in the General Populationpercentage of participants with FEV1< lower limit of normal (LLN)145 Participants
General Population (15-30 Years)Abnormal Lung Function in the General Populationpercentage of participants with FEV1/FVC< lower limit of normal (LLN)133 Participants
General Population (30-45 Years)Abnormal Lung Function in the General Populationpercentage of participants with FEV1/FVC< lower limit of normal (LLN)211 Participants
General Population (30-45 Years)Abnormal Lung Function in the General Populationpercentage of participants with FEV1< lower limit of normal (LLN)178 Participants
General Population (30-45 Years)Abnormal Lung Function in the General Populationpercentage of participants with FVC< lower limit of normal (LLN)96 Participants
General Population (45-60 Years)Abnormal Lung Function in the General Populationpercentage of participants with FVC< lower limit of normal (LLN)108 Participants
General Population (45-60 Years)Abnormal Lung Function in the General Populationpercentage of participants with FEV1< lower limit of normal (LLN)226 Participants
General Population (45-60 Years)Abnormal Lung Function in the General Populationpercentage of participants with FEV1/FVC< lower limit of normal (LLN)259 Participants
General Population (60-82 Years)Abnormal Lung Function in the General Populationpercentage of participants with FVC< lower limit of normal (LLN)143 Participants
General Population (60-82 Years)Abnormal Lung Function in the General Populationpercentage of participants with FEV1< lower limit of normal (LLN)252 Participants
General Population (60-82 Years)Abnormal Lung Function in the General Populationpercentage of participants with FEV1/FVC< lower limit of normal (LLN)235 Participants

Source: ClinicalTrials.gov · Data processed: Sep 18, 2026