Białystok PLUS - Polish Longitudinal University Study

NCT03197363 | Enrolling By Invitation DMC

• 1 other identifier: B+
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases; Diabetes; Neuro-Degenerative Disease; Obesity; Pulmonary Disease; Neoplastic Disease

Keywords

Civilization diseases; Cardiovascular Risk Factor; Population study; Intestinal microbiome; Oral microbiome

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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.

Interventions

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.

Białystok PLUS

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• disagreement of the invited person

Sponsors & Collaborators

• Medical University of Bialystok: lead
• University Medicine Greifswald: collaborator
• City of Białystok: collaborator
• Marshall's Office of Podlaskie Voivodship: collaborator

Study Sites (1)

Medical University of Bialystok

Bialystok, 15-089, Poland

Location

Related Links

• This page contains information about Bialystok PLUS study.

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples: Serum, plasma (will be collected from fasting blood samples) In this study we will be isolated Peripheral Blood Mononuclear Cells (PBMC) from fresh blood sampled on EDTA as anticoagulant. Saliva samples (unstimulated and stimulated) Urine samples Stool samples (for analysis intestinal microbiome)

MeSH Terms

Conditions

Cardiovascular Diseases; Diabetes Mellitus; Obesity; Lung Diseases; Neoplasms

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiratory Tract Diseases

Study Officials

• Karol A. Kaminski, Professor

  Medical University of Bialystok

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2017
• First Posted: June 23, 2017
• Study Start: November 5, 2018
• Primary Completion: December 1, 2024
• Study Completion (Estimated): December 1, 2029
• Last Updated: March 15, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share

Locations

PL (1)