Clinical trial NCT03197363: Białystok PLUS - Polish Longitudinal University Study
Official title: Bialystok PLUS - Polish Longitudinal University Study
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Cardiovascular Diseases
Diabetes
Neuro-Degenerative Disease
Obesity
Pulmonary Disease
Neoplastic Disease
Keywords: Civilization diseases
Cardiovascular Risk Factor
Population study
Intestinal microbiome
Oral microbiome
Lead sponsor: Medical University of Bialystok
Sponsor class: OTHER
Collaborators: name: University Medicine Greifswald
name: City of Białystok
name: Marshall's Office of Podlaskie Voivodship
First posted: 2017-06-23
Enrollment: 10000
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Inhabitants of Bialystok (selected from the registry of Bialystok inhabitants). Stratified sampling will be performed, based on sex and age strata (10-year intervals) in order the sample to be representative for gender and age distribution in Bialystok population.

Brief 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.

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.

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

Primary outcomes:
measure: Death or the occurrence of diseases
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Białystok
country: Poland
facility: Medical University of Bialystok
Study officials:
affiliation: Medical University of Bialystok
name: Karol A. Kaminski, Professor
role: PRINCIPAL_INVESTIGATOR
References: