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The Silesia Diabetes-Heart Project

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ClinicalTrials.gov Identifier: NCT05626413
Recruitment Status : Recruiting
First Posted : November 23, 2022
Last Update Posted : November 23, 2022
Sponsor:
Collaborators:
Silesian University of Technology
University of Liverpool
Information provided by (Responsible Party):
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 and cardiovascular events using machine learning approach.

Condition or disease
Diabetes Mellitus

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 4000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Cardiovascular Disease and Diabetes in Silesian Patients
Actual Study Start Date : January 1, 2015
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : January 31, 2026



Primary Outcome Measures :
  1. The risk of cardiovascular disease and events among patients with diabetes [ Time Frame: 5 years ]
    To predict the risk of cardiovascular disease and events among patients with diabetes using machine learning approach



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients hospitalized in diabetology clinic in Zabrze. Patients treated in outpatient diabetology clinics in Silesia region.
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: patients with diabetes type 1 or type 2.

Exclusion Criteria:

For the group of hospitalized patients: other types of diabetes than type 1 and type 2 diabetes.Patients who day during hospital stay, terminal stage of cancer.

For the subgroup of patients recruited form outpatient diabetology clinics: lack of an informed consent, other types of diabetes than type 1 and type 2 diabetes,malignant neoplasms, terminal stage of neoplasm, end-stage renal disease, diagnosed malabsorption syndrome, active infection, primary hyperparathyroidism.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05626413


Contacts
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Contact: Katarzyna Nabrdalik, PhD, prof. 0048697592954 knabrdalik@sum.edu.pl
Contact: Hanna Kwiendacz, PhD 0048509774849 hkwiendacz@sum.edu.pl

Locations
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Poland
Department of Internal Diseases, Diabetology and Nephrology Recruiting
Zabrze, Poland, 41-800
Contact: Hanna Kwiendacz, MD,PhD    0048509774849    hkwiendacz@sum.edu.pl   
Contact: Katarzyna Nabrdalik, MD,PhD,prof    0048697592954    knabrdalik@sum.edu.pl   
Principal Investigator: Katarzyna Nabrdalik, MD, PhD         
Sub-Investigator: Janusz Gumprecht, MD,PhD,Prof         
Sub-Investigator: Hanna Kwiendacz, MD,PhD         
Sub-Investigator: Karolina Drożdż, MD         
Sub-Investigator: Jakub Nalepa, PhD, prof.         
Sponsors and Collaborators
Medical University of Silesia
Silesian University of Technology
University of Liverpool
Investigators
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Principal Investigator: Katarzyna Nabrdalik, PhD,prof. Medical University of Silesia
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Responsible Party: Medical University of Silesia
ClinicalTrials.gov Identifier: NCT05626413    
Other Study ID Numbers: Silesia diabetes - heart
First Posted: November 23, 2022    Key Record Dates
Last Update Posted: November 23, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
Cardiovascular disease
Diabetes mellitus
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases