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

Recruiting

• Conditions: Diabetes Mellitus

• Registration Number: NCT05626413
• Lead Sponsor: 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, cardiovascular events and neuropathy 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, 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 Timeline

• Study Start: 2015-01-01
• Study First Submitted: 2022-11-15
• Study First Submitted QC: 2022-11-15
• Study First Posted: 2022-11-23
• Status Verified: 2023-09
• Last Update Submitted: 2024-04-09
• Last Update Posted: 2024-04-10
• Primary Completion: 2025-12-31
• Study Completion: 2026-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 4000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Department of Internal Diseases, Diabetology and Nephrology; 🇵🇱 Zabrze, Poland