Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT03197363 |
| Other study ID # |
B+ |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
November 5, 2018 |
| Est. completion date |
December 2029 |
Study information
| Verified date |
March 2023 |
| Source |
Medical University of Bialystok |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The main goal of the study is to provide a unique multidimensional picture of the health of
the population with simultaneous optimal standards of sampling, processing and storing of
data and biomaterial that will allow discovering novel mechanisms in the development and
progression of common civilization diseases. In the effect it will improve prevention,
diagnosis and treatment.
Description:
One of the objectives of this project is to obtain comprehensive information on the health
status (including subclinical disorders), genomics, risk factors, health behavior and
sociodemographic data from large, representative sample of population of Białystok city
inhabitants.
The study will assess many systems, the major emphasis will be given to the most common
diseases associated with modern lifestyle (civilization diseases): cardiovascular, metabolic
and endocrine, neurodegenerative, neoplastic and pulmonary. There are many interactions
between them that might be missed when not analyzed together. Apart from those most common
diseases we will also asses others, including allergies, airway dysfunction - both upper and
lower, urinary incontinency, gastrointestinal disorders, eye diseases. There may be many
common underlying mechanisms of the diseases that now seem to be distant and independent,
because of insufficient knowledge.
Health status assessment will refer to many areas of medicine and will include clinical data,
medical images, as well as biological samples and voice recording samples. We plan to combine
imaging (fundoscopy, ultrasound examinations of heart, vessels, thyroid, liver) with state of
the art functional studies (AGE measurement, pulse wave velocity, central pressure,
plethysmography with the analysis of diffusing capacity of lung for carbon monoxide and NO
concentration, spiroergometry, oral glucose tolerance test.
Voice samples will be analyzed in the speech analysis software, it will help in the diagnosis
of civilization diseases such as diabetes, depression, and atherosclerosis.
Participants will fill in detailed questionnaires that will provide information about their
family history, dietary habits, socioeconomic status, stress coping strategies, lifestyle,
exposure to harmful environment, various symptoms, history of diagnosed diseases and
treatment.
The study is designed as prospective, so in the future, additional information on occurrence
of diseases or deaths will allow to estimate disease incidence, morbidity or mortality in
studied population.
