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

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: Diabetes Mellitus

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

• Study Contact: Name: Katarzyna Nabrdalik, PhD, prof.; Phone Number: 0048697592954; Email: knabrdalik@sum.edu.pl
• Study Contact Backup: Name: Hanna Kwiendacz, PhD; Phone Number: 0048509774849; Email: hkwiendacz@sum.edu.pl

Study Locations

• Poland
  • Zabrze, Poland, 41-800
    • Recruiting
    • Department of Internal Diseases, Diabetology and Nephrology
    • Contact: Hanna Kwiendacz, MD,PhD; Phone Number: 0048509774849; Email: hkwiendacz@sum.edu.pl
    • Contact: Katarzyna Nabrdalik, MD,PhD,prof; Phone Number: 0048697592954; Email: knabrdalik@sum.edu.pl
    • Principal Investigator: Katarzyna Nabrdalik, MD, PhD
    • Sub-Investigator: Janusz Gumprecht, MD,PhD,Prof
    • Sub-Investigator: Hanna Kwiendacz, MD,PhD

Participation Criteria

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

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	To predict the risk of cardiovascular disease and events among patients with diabetes using machine learning approach	5 years

Collaborators and Investigators

• 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

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: Cardiovascular disease; Diabetes mellitus
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Cardiovascular Diseases; Diabetes Mellitus
• 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