The Austrian LEAD (Lung hEart sociAl boDy) Study (LEAD)

November 21, 2024 updated by: Ludwig Boltzmann Institute for Lung Health
The LEAD study is the first longitudinal cohort investigating respiratory, cardiac, and metabolic health in a reference population of Austria.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

14966

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1140
        • The LEAD Study Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Community based cohort

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Insufficient language skills
  • pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Reference Population
No Intervention
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Longitudinal study of the natural history of lung function growth and decline (NATHIS)
Time Frame: 12 years
Lung growths until the age of 15 in females and in the mid-20s in males and declines over time. Compared to female, lung function decline in male starts after a plateau phase and lung function decline is slightly higher compared to female.However, until now it is unclear if female smokers are more susceptible to the deleterious effects of tobacco smoking than male. Therefore, the aims are: 1.To investigate the natural history of lung function in a "healthy population" (defined by a population free of respiratory symptoms and/or disease, metabolic, cardiovascular and/or mental diseases) and to determine normal lung function growth and decline over time. 2.To investigate the influence of smoking, smoking cessation, air pollution (urban vs. rural), socioeconomic status (income, education, and occupation), allergy, bronchial hyperactivity and systemic inflammation on lung function growth and decline over time. 3.To identify the risk factors for accelerated decline of lung function.
12 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ludwig Boltzmann Institute for Lung Health

Investigators

  • Principal Investigator: Robab Breyer-Kohansal, Prof. Dr., Ludwig Boltzmann Institute for Lung Health, Vienna, Austria
  • Study Director: Marie-Kathrin Breyer, Prof. Dr, Ludwig Boltzmann Institute for Lung Health, Vienna, Austria

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2011

Primary Completion (Actual)

October 1, 2016

Study Completion (Estimated)

October 1, 2028

Study Registration Dates

First Submitted

November 4, 2012

First Submitted That Met QC Criteria

November 15, 2012

First Posted (Estimated)

November 16, 2012

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

November 21, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LEAD1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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