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

Sponsor
Medical University of Silesia (Other)
Overall Status
Recruiting
CT.gov ID
NCT05626413
Collaborator
Silesian University of Technology (Other), University of Liverpool (Other)
4,000
1
133
30.1

Study Details

Study Description

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 and cardiovascular events using machine learning approach.

Condition or Disease Intervention/Treatment Phase

    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, and peripheral and cardiovascular neuropathy. 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.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    4000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Cardiovascular Disease and Diabetes in Silesian Patients
    Actual Study Start Date :
    Jan 1, 2015
    Anticipated Primary Completion Date :
    Dec 31, 2025
    Anticipated Study Completion Date :
    Jan 31, 2026

    Outcome Measures

    Primary Outcome Measures

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    1. 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Internal Diseases, Diabetology and Nephrology Zabrze Poland 41-800

    Sponsors and Collaborators

    • Medical University of Silesia
    • Silesian University of Technology
    • University of Liverpool

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Medical University of Silesia
    ClinicalTrials.gov Identifier:
    NCT05626413
    Other Study ID Numbers:
    • Silesia diabetes - heart
    First Posted:
    Nov 23, 2022
    Last Update Posted:
    Dec 6, 2022
    Last Verified:
    Sep 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Medical University of Silesia
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 6, 2022