Clinical trial NCT05626413: Cardiovascular Disease in Patients With Diabetes: The Silesia Diabetes-Heart Project
Official title: Cardiovascular Disease and Diabetes in Silesian Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetes Mellitus
Keywords: Cardiovascular disease
Diabetes mellitus
Lead sponsor: Medical University of Silesia
Sponsor class: OTHER
Collaborators: name: Silesian University of Technology
name: Liverpool Centre for Cardiovascular Science at University of Liverpool, Liverpool John Moores University and Liverpool Heart & Chest Hospital
First posted: 2022-11-23
Enrollment: 4000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients hospitalized in diabetology ward in Zabrze. Patients treated in outpatient diabetology clinics in Silesia region.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The risk of cardiovascular disease and events among patients with diabetes
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Zabrze
country: Poland
facility: Department of Internal Diseases, Diabetology and Nephrology
Study officials:
affiliation: Medical University of Silesia
name: Katarzyna Nabrdalik, PhD,prof.
role: PRINCIPAL_INVESTIGATOR
References: