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

Diabetes Mellitus Clinical Trial

Official title:

Cardiovascular Disease and Diabetes in Silesian Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05626413
• Other study ID #: Silesia Diabetes-Heart Project
• Status: Recruiting
• Start date: January 1, 2015
• Est. completion date: January 31, 2026

Study information

• Verified date: September 2023
• Source: Medical University of Silesia
• Contact: Katarzyna Nabrdalik, PhD, prof.
• Phone: 0048697592954
• Email: knabrdalik[@]sum.edu.pl
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4000
• Est. completion date: January 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Diabetes Mellitus

Locations

Country	Name	City	State
Poland	Department of Internal Diseases, Diabetology and Nephrology	Zabrze

Sponsors (3)

Lead Sponsor	Collaborator
Medical University of Silesia	Liverpool Centre for Cardiovascular Science at University of Liverpool, Liverpool John Moores University and Liverpool Heart & Chest Hospital, Silesian University of Technology

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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