Cardiovascular Disease in Patients With Diabetes: The Silesia Diabetes-Heart Project

April 9, 2024 updated by: Medical University of Silesia

Cardiovascular Disease and Diabetes in Silesian Patients

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, cardiovascular events and neuropathy using machine learning approach.

Study Overview

Status

Recruiting

Conditions

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, electrocardiography, peripheral and cardiovascular autonomic neuropathy and fundus imaging. 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.

The secondary aim of the study is to utilize fundus imaging, electrocardiography, alongside demographic and clinical data in order to potentially diagnose neuropathy.

Study Type

Observational

Enrollment (Estimated)

4000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Poland
      • Zabrze, Poland, 41-800
        • Recruiting
        • Department of Internal Diseases, Diabetology and Nephrology
        • Contact:
        • Contact:
        • Principal Investigator:
          • Katarzyna Nabrdalik, MD, PhD
        • Sub-Investigator:
          • Janusz Gumprecht, MD,PhD,Prof
        • Sub-Investigator:
          • Hanna Kwiendacz, MD,PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients hospitalized in diabetology ward in Zabrze. Patients treated in outpatient diabetology clinics in Silesia region.

Description

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: diabetes type 1 or type 2

Exclusion Criteria:

  1. For the group of hospitalized patients:

    • Types of diabetes other than type 1 and type 2 diabetes
    • Death during hospital stay
    • Terminal stage of cancer.

  2. For the subgroup of patients recruited form outpatient diabetology clinics:

    • Lack of an informed consent
    • Types of diabetes other than type 1 and type 2 diabetes
    • Malignant neoplasms
    • Terminal stage of neoplasm
    • End-stage renal disease
    • Malabsorption syndrome
    • Active infection
    • Primary hyperparathyroidism

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Silesia

Collaborators

Silesian University of Technology
Liverpool Centre for Cardiovascular Science at University of Liverpool, Liverpool John Moores University and Liverpool Heart & Chest Hospital

Investigators

  • Principal Investigator: Katarzyna Nabrdalik, PhD,prof., Medical University of Silesia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

January 31, 2026

Study Registration Dates

First Submitted

November 15, 2022

First Submitted That Met QC Criteria

November 15, 2022

First Posted (Actual)

November 23, 2022

Study Record Updates

Last Update Posted (Actual)

April 10, 2024

Last Update Submitted That Met QC Criteria

April 9, 2024

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Silesia Diabetes-Heart Project

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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