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Enrolling by invitation NCT03197363

Białystok PLUS - Polish Longitudinal University Study

Observational Cardiovascular Diseases Diabetes Neuro-Degenerative Disease Obesity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Discovering novel risk factors..
Who it may be relevant to
Registry conditions: Cardiovascular Diseases, Diabetes, Neuro-Degenerative Disease, Obesity. Basic parameters: 20 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Poland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Bialystok PLUS - Polish Longitudinal University Study

Overview

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.

Detailed 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.

Interventions

  • Other Discovering novel risk factors.
    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 vario

Primary outcome measures

  • Death or the occurrence of diseases [Time frame: 5 years]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • disagreement of the invited person

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Poland · 1 center
  • Medical University of Bialystok — Bialystok

Identifiers

NCT: NCT03197363 · B+

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗