Clinical trial NCT01727518: The Austrian LEAD (Lung hEart sociAl boDy) Study
Official title: The Austrian LEAD (Lung hEart sociAl boDy) Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Respiration Disorders
Body Composition, Beneficial
Metabolic Health
Keywords: natural history
lung function
general population
metabolic health
Lead sponsor: Ludwig Boltzmann Institute for Lung Health
Sponsor class: OTHER
First posted: 2012-11-16
Enrollment: 14966
Sex: ALL
Minimum age (years): 6
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Community based cohort

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Insufficient language skills
* pregnancy

Primary outcomes:
measure: Abnormal Lung Function in the General Population
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: The LEAD Study Center
Study officials:
affiliation: Ludwig Boltzmann Institute for Lung Health, Vienna, Austria
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
References:
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.
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.