The Silesia Diabetes-Heart Project

Overview

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.

Full Title of Study: “Cardiovascular Disease and Diabetes in Silesian Patients”

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 31, 2025

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.

Clinical Trial Outcome Measures

Primary Measures

  • The risk of cardiovascular disease and events among patients with diabetes
    • Time Frame: 5 years
    • To predict the risk of cardiovascular disease and events among patients with diabetes using machine learning approach

Participating in This Clinical Trial

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 Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Medical University of Silesia
  • Collaborator
    • Silesian University of Technology
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Katarzyna Nabrdalik, PhD,prof., Principal Investigator, Medical University of Silesia
  • Overall Contact(s)
    • Katarzyna Nabrdalik, PhD, prof., 0048697592954, knabrdalik@sum.edu.pl

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