Body Composition, Beneficial, Metabolic Health, Respiration Disorders
Conditions
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
As the LEAD study is an observational cohort study, there is no intervention to report.
Sponsors
Study design
Eligibility
Inclusion criteria
* Male and Female, * Age 6 - 80 years, * Invitation by study invitation letter
Exclusion criteria
* Insufficient language skills * pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Abnormal Lung Function in the General Population | 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. |
Countries
Austria
Contacts
Ludwig Boltzmann Institute for Lung Health, Vienna, Austria
Ludwig Boltzmann Institute for Lung Health, Vienna, Austria
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Reference Population No Intervention; obersvation healthy group (no symptoms and no lung function impairment) | 14,966 |
| Total | 14,966 |
Baseline characteristics
| Characteristic | Reference 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 type | EG000 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
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| General Population (6-15 Years) | Abnormal Lung Function in the General Population | percentage of participants with FVC< lower limit of normal (LLN) | 52 Participants |
| General Population (6-15 Years) | Abnormal Lung Function in the General Population | percentage of participants with FEV1< lower limit of normal (LLN) | 65 Participants |
| General Population (6-15 Years) | Abnormal Lung Function in the General Population | percentage of participants with FEV1/FVC< lower limit of normal (LLN) | 44 Participants |
| General Population (15-30 Years) | Abnormal Lung Function in the General Population | percentage of participants with FVC< lower limit of normal (LLN) | 121 Participants |
| General Population (15-30 Years) | Abnormal Lung Function in the General Population | percentage of participants with FEV1< lower limit of normal (LLN) | 145 Participants |
| General Population (15-30 Years) | Abnormal Lung Function in the General Population | percentage of participants with FEV1/FVC< lower limit of normal (LLN) | 133 Participants |
| General Population (30-45 Years) | Abnormal Lung Function in the General Population | percentage of participants with FEV1/FVC< lower limit of normal (LLN) | 211 Participants |
| General Population (30-45 Years) | Abnormal Lung Function in the General Population | percentage of participants with FEV1< lower limit of normal (LLN) | 178 Participants |
| General Population (30-45 Years) | Abnormal Lung Function in the General Population | percentage of participants with FVC< lower limit of normal (LLN) | 96 Participants |
| General Population (45-60 Years) | Abnormal Lung Function in the General Population | percentage of participants with FVC< lower limit of normal (LLN) | 108 Participants |
| General Population (45-60 Years) | Abnormal Lung Function in the General Population | percentage of participants with FEV1< lower limit of normal (LLN) | 226 Participants |
| General Population (45-60 Years) | Abnormal Lung Function in the General Population | percentage of participants with FEV1/FVC< lower limit of normal (LLN) | 259 Participants |
| General Population (60-82 Years) | Abnormal Lung Function in the General Population | percentage of participants with FVC< lower limit of normal (LLN) | 143 Participants |
| General Population (60-82 Years) | Abnormal Lung Function in the General Population | percentage of participants with FEV1< lower limit of normal (LLN) | 252 Participants |
| General Population (60-82 Years) | Abnormal Lung Function in the General Population | percentage of participants with FEV1/FVC< lower limit of normal (LLN) | 235 Participants |