Other Clinical Trial - Cardiovascular Disease in Patients With Diabetes:

Status Recruiting

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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05626413
Study type	Observational [Patient Registry]
Source	Medical University of Silesia
Contact	Katarzyna Nabrdalik, PhD, prof.
Phone	0048697592954
Email	knabrdalik@sum.edu.pl
Status	Recruiting
Phase
Start date	January 1, 2015
Completion date	January 31, 2026

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms