Cardiovascular Disease in Patients With Diabetes: The Silesia Diabetes-Heart Project
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 |
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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
Outcome Measures
Primary Outcome Measures
- 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
Inclusion Criteria:
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For the group of hospitalized patients: diabetes type 1 or type 2
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For the subgroup of patients treated in outpatient diabetology clinics in Silesia region: diabetes type 1 or type 2
Exclusion Criteria:
- For the group of hospitalized patients:
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Types of diabetes other than type 1 and type 2 diabetes
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Death during hospital stay
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Terminal stage of cancer.
- For the subgroup of patients recruited form outpatient diabetology clinics:
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Lack of an informed consent
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Types of diabetes other than type 1 and type 2 diabetes
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Malignant neoplasms
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Terminal stage of neoplasm
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End-stage renal disease
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Malabsorption syndrome
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Active infection
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Primary hyperparathyroidism
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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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.- Silesia diabetes - heart