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Enrolling by Invitation

NCT Number: NCT03197363

Białystok PLUS - Polish Longitudinal University Study

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • inhabitants of Bialystok (randomly selected from the registry of Bialystok inhabitants)
  • age 20-80

Exclusion criteria

  • disagreement of the invited person

Treatment and study plan

Discovering novel risk factors.

Other

The study protocol includes multiple imaging and functional investigations (including heart, carotid, thyroid, liver ultrasound, fundoscopy, plethysmography, pulse wave velocity, ankle-brachial index, ECG, body composition measured by bioimpedance and dual energy x-ray absorptiometry, anthropometric assessment, rhinometry, hand grip test, oral glucose tolerance test, advance glycation end-products measurement, voice recording. There will be a detailed and verified questionnaires concerning various activities of the subject: physical activity, depression, sino-nasal symptoms, prostate hypertrophy, female urinary tract symptoms, quality of life, smoking and drinking addiction, hirsutism.

Primary outcomes

  1. Death or the occurrence of diseases

    Time frame: 5 years

    Death or the occurrence of diseases: cardiovascular diseases, diabetes, neuro-degenerative diseases, obesity, pulmonary diseases, neoplastic diseases

Sponsors and collaborators

Lead sponsor

Medical University of Bialystok

Other

Collaborators

  • City of Białystok
  • Marshall's Office of Podlaskie Voivodship
  • University Medicine Greifswald

Registry information

Official study title

Bialystok PLUS - Polish Longitudinal University Study

Acronym: Bialystok+

Important dates

Study start
2018
Primary completion
2024
Study completion
2029
First posted
Jun 23, 2017
Registry last updated
Mar 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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