Białystok PLUS - Polish Longitudinal University Study (Bialystok+)

Bialystok 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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Cardiovascular Diseases; Obesity; Diabetes; Pulmonary Disease; Neuro-Degenerative Disease; Neoplastic Disease
• Intervention / Treatment: Other: Discovering novel risk factors.

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.

• Study Type: Observational
• Enrollment (Anticipated): 10000

Contacts and Locations

Study Locations

• Poland
  • Białystok, Poland, 15-089
    • Medical University of Bialystok

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• disagreement of the invited person

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Białystok PLUS; Participation in the study will be offered to 10000 inhabitants of Bialystok aged 20-80 years. They will be randomly selected from the registry of Bialystok inhabitants. The goal of study is to discover novel risk factors and mechanisms underlying civilization diseases.

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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Death or the occurrence of diseases	Death or the occurrence of diseases: cardiovascular diseases, diabetes, neuro-degenerative diseases, obesity, pulmonary diseases, neoplastic diseases	5 years

Collaborators and Investigators

• Sponsor: Medical University of Bialystok
• Collaborators: University Medicine Greifswald; City of Białystok; Marshall's Office of Podlaskie Voivodship
• Investigators: Principal Investigator: Karol A. Kaminski, Professor, Medical University of Bialystok

Publications and helpful links

Helpful Links

• This page contains information about Bialystok PLUS study.

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2018
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): December 1, 2029

Study Registration Dates

• First Submitted: June 20, 2017
• First Submitted That Met QC Criteria: June 20, 2017
• First Posted (Actual): June 23, 2017

Study Record Updates

• Last Update Posted (Actual): March 15, 2023
• Last Update Submitted That Met QC Criteria: March 14, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Cardiovascular Risk Factor; Oral microbiome; Civilization diseases; Population study; Intestinal microbiome
• Additional Relevant MeSH Terms: Nervous System Diseases; Neoplasms; Cardiovascular Diseases; Neurodegenerative Diseases
• Other Study ID Numbers: B+

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Scientists and researchers who collaborate on Bialystok PLUS study organization have access to results of examinations and analyses of biological material. Personal data are protected and only designated persons have access to them.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No