Work package 4

Building the PARASOL-cohort for detection of early lung damage and cardiometabolic disease

In WP1, risk areas and risk populations for lung diseases in the Netherlands will be identified. However, not everybody in these risk areas or that belong to these risk populations will eventually develop lung disease and early detection of disease remains a problem. A gradual decline in lung function caused by early damage usually happens without being noticed, as most young people have an enormous overcapacity in their respiratory system. Together with the decline in lung function, extra-pulmonary manifestations (e.g. muscle wasting, bone loss, decreased cardiovascular and cognitive function) might be present or can be developed without being noticed. Once a patient develops complaints the disease process usually has already proceeded beyond the point of no return. It is hardly possible to cure these patients and most of the treatments are only there to relieve complaints. We hypothesize that it would be important to identify easy to measure biomarkers that allow us to diagnose lung damage at a much earlier stage and that can optimize therapy to prevent the occurrence of lung disease. Risk factors for cardiometabolic diesease are comparable to the risk factors for lung disease. Therefore, we are also interested in studying those diseases in a cohort.

This work package describes setting up the PARASOL (Prevention of And Risk fActorS for chronic diseases: an Observational study in North HoLland) cohort for studying differences between people with high risk and normal/moderate risk of lung diseases and cardiometabolic diseases with the goal to diagnose such diseases at an earlier stage.

The primary objectives are:

To examine how environmental exposures influence the prevalence, 5-year incidence and progression of cardiometabolic and chronic respiratory disease in the general population.
To determine the mediation effect of lifestyle factors and ‘omics profiles (i.e., biological mechanisms) in the associations between environmental exposures and the development and progression of cardiometabolic and chronic respiratory disease.
To detect biomarkers and treatable targets for early lung damage and cardiometabolic diseases.

A total of 3000 people (aged 30-55 year) will be invited to join the study. Half of this sample will be a random sample from this age group within the greater Amsterdam and Hoorn areas, the other half will be selected from high risk groups in these areas, as identified in WP1.

All 3000 participants will be invited for two study visits: 1) at baseline; 2) after five years of follow-up. We will collect urine and faeces. The following measurements will be performed during the study visits: anthropometry, blood pressure, lung function, exhaled breath, nasal sampling, questionnaires, collection of fasting blood samples, and an Oral Glucose Tolerance Test. After both study visits, participants will complete the questionnaires at home, they will wear an accelerometer for seven days and track their nutritional intake through an app on their mobile phone for a maximum of 12 days. They will also have the opportunity to take a food intolerance test at baseline. Finally, participants will be requested to fill out electronic questionnaires once a year at home between the baseline study visit and study visit at t = 5 years.

In a subgroup of 350 persons (aged 40-55 years old) we will perform additional measurements. A CT scan of the chest will be made at both time points and personal exposome measurements (including home visits). The subgroup will also be invited for a visit at t=1 year, for anthropometry, blood pressure, lung function, exhaled breath, nasal sampling, questionnaires, collection of fasting blood samples, accelerometer, and nutritional intake. Participants of the subgroup who have an indication for referral to a combined lifestyle intervention reimbursed by basic insurance (obesity, or overweight with a cardiometabolic risk factor) will be informed about the opportunity to participate in the Coaching on Lifestyle (CooL) program.

The first deliverable of this work package is the PARASOL cohort with patient data/study samples collected over 5 years of time. The subgroup will be selected for measurement of exposome characteristics using wearable devices (WP5). The samples will be used to define biomarkers of early lung damage and cardiometabolic disease that can help in early detection of patients (WP6). Participants in the subgroup will be participating in imaging studies (WP7) and a personalized lifestyle intervention (WP9).