The Silesia Diabetes-Heart Project

Cardiovascular Disease and Diabetes in Silesian Patients

Sponsors

Lead Sponsor: Medical University of Silesia

Collaborator: Silesian University of Technology
University of Liverpool

Source Medical University of Silesia
Brief Summary

The project is an observational one which undertakes different, easy to obtain in everyday clinical practice, demographical, laboratory and clinical parameters of patients with diabetes in Silesian Region in Poland to predict cardiovascular disease and cardiovascular events using machine learning approach.

Detailed Description

The study is a prospective, observational one in which it is planned to obtain demographical, laboratory and clinical parameters of patients who are hospitalized in one the the main diabetology sites in Silesia region in Poland and to follow them prospectively for 10 years in order to collect information related to new cardiovascular events. Telephone contact will be performed every 12 months following hospital discharge. Any procedures related to the patients hospitalized in the diabetology ward will be the routine ones and the bioethics committee of Medical University of Silesia gave the permission for the study but waved the necessity of informed consent to be signed.Moreover there will be subgroup analysis of patients recruited from the outpatient diabetology clinics in Silesia region in order to participate in the observational study collecting data related to to vitamin D concentration, densitometry, fibroscan, carotid ultrasound examination, vascular stiffness, and peripheral and cardiovascular neuropathy. Patients who are treated in outpatient diabetology clinics in Silesia region and are included into the study must have the informed consent signed and bioethics committee agreement has been obtained. Machine learning approach will be implemented to discover the association between easy to obtain in everyday practice parameters, namely clinical, biochemical, and demographical ones to identify patients at the highest risk of cardiovascular disease.

Overall Status Recruiting
Start Date 2015-01-01
Completion Date 2026-01-31
Primary Completion Date 2025-12-31
Study Type Observational [Patient Registry]
Primary Outcome
Measure Time Frame
The risk of cardiovascular disease and events among patients with diabetes 5 years
Enrollment 4000
Condition
Eligibility

Sampling Method:

Non-Probability Sample

Criteria:

Inclusion Criteria: For the group of hospitalized patients: diabetes type 1 or type 2. For the subgroup of patients treated in outpatient diabetology clinics in Silesia region: patients with diabetes type 1 or type 2. Exclusion Criteria: For the group of hospitalized patients: other types of diabetes than type 1 and type 2 diabetes.Patients who day during hospital stay, terminal stage of cancer. For the subgroup of patients recruited form outpatient diabetology clinics: lack of an informed consent, other types of diabetes than type 1 and type 2 diabetes,malignant neoplasms, terminal stage of neoplasm, end-stage renal disease, diagnosed malabsorption syndrome, active infection, primary hyperparathyroidism.

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Katarzyna Nabrdalik, PhD,prof. Principal Investigator Medical University of Silesia
Overall Contact

Last Name: Katarzyna Nabrdalik, PhD, prof.

Phone: 0048697592954

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup: Investigator: Department of Internal Diseases, Diabetology and Nephrology Hanna Kwiendacz, MD,PhD 0048509774849 [email protected] Katarzyna Nabrdalik, MD, PhD Principal Investigator Janusz Gumprecht, MD,PhD,Prof Sub-Investigator Hanna Kwiendacz, MD,PhD Sub-Investigator Karolina Drożdż, MD Sub-Investigator Jakub Nalepa, PhD, prof. Sub-Investigator
Location Countries

Poland

Verification Date

2022-09-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Patient Data No
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

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