Cardiovascular DiseasesBialystok+NCT03197363
Białystok PLUS - Polish Longitudinal University Study
An observational study of Cardiovascular Diseases and Diabetes, run by Medical University of Bialystok at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Cardiovascular Diseases, Diabetes, Neuro-Degenerative Disease
- What is being tested?
- Discovering novel risk factors.
- Type of treatment
- Pill or oral medicine
- How many people
- 8,320 participants
- Where
- 1 sitePoland
- Study dates
- 5 Nov 2018to Jun 2034
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- inhabitants of Bialystok (randomly selected from the registry of Bialystok inhabitants)
- age 20-80
Who cannot join
- disagreement of the invited person
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site
Population Research Center, Medical University of Bialystok
Bialystok, 15-274
About this study
Official title: 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.
Read the 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.
- Conditions
- Cardiovascular Diseases, Diabetes, Neuro-Degenerative Disease, Obesity, Pulmonary Disease, Neoplastic Disease
- Being tested
- Discovering novel risk factors.
- Keywords
- Civilization diseases, Cardiovascular Risk Factor, Population study, Intestinal microbiome, Oral microbiome
- Medical subject headings
- Cardiovascular Diseases, Diabetes Mellitus, Obesity, Lung Diseases, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Białystok PLUS | Participation in the study wwas offered to 8320 inhabitants of Bialystok aged 20-80 years. They were randomly selected from the registry of Bialystok inhabitants. Actual number of assessed individuals was 3527. The goal of study is to discover novel risk factors and mechanisms underlying civilization diseases. Receives: Other: Discovering novel risk factors. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death or the occurrence of diseases
Death or the occurrence of diseases: cardiovascular diseases, diabetes, neuro-degenerative diseases, obesity, pulmonary diseases, neoplastic diseases
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2017
- Study start5 Nov 2018
- Primary completionDec 2030 (estimated)
- Study completionJun 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8,320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Bialystok
- Sponsor type
- University, hospital or other
- Collaborators
- University Medicine Greifswald, City of Białystok, Marshall's Office of Podlaskie Voivodship
- Responsible party
- Sponsor
- Investigators
- Karol A. Kaminski, Professor, Principal investigator, Medical University of Bialystok
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03197363
- Sponsor's protocol ID
- B+
- Acronym
- Bialystok+
- Status last verified
- Oct 2026
- First submitted
- 20 Jun 2017
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bialystok PLUS - Polish Longitudinal University Study
- ClinicalTrials.gov ID
- NCT03197363
- Acronym / sponsor ID
- Bialystok+ / B+
- Conditions
- Cardiovascular Diseases, Diabetes, Neuro-Degenerative Disease, Obesity, Pulmonary Disease, Neoplastic Disease
- Keywords
- Civilization diseases, Cardiovascular Risk Factor, Population study, Intestinal microbiome, Oral microbiome
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 8,320 participants (estimated)
- Lead sponsor
- Medical University of BialystokUniversity, hospital or other
- Collaborators
- University Medicine Greifswald, City of Białystok, Marshall's Office of Podlaskie Voivodship
- Study start
- 5 Nov 2018 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Jun 2034 (estimated)
- First posted
- 23 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Białystok PLUS | – | Other: Discovering novel risk factors.Participation in the study wwas offered to 8320 inhabitants of Bialystok aged 20-80 years. They were randomly selected from the registry of Bialystok inhabitants. Actual number of assessed individuals was 3527. The goal of study is to discover novel risk factors and mechanisms underlying civilization diseases. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- inhabitants of Bialystok (randomly selected from the registry of Bialystok inhabitants)
- age 20-80
Key exclusion criteria (1 listed)
- disagreement of the invited person
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Białystok PLUS |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- This page contains information about Bialystok PLUS study.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Karol A. Kaminski, Professor principal investigator
Medical University of Bialystok
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Diabetes, run by Medical University of Bialystok at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death or the occurrence of diseases (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.