Observing cardiovascular disease in diabetes patients in Silesia
Cardiovascular Disease and Diabetes in Silesian Patients
This study is trying to see if collecting health information from diabetes patients in Silesia can help predict heart problems over the next 10 years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 4000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medical University of Silesia Academic / other |
| Locations | 1 site (Zabrze) |
| Trial ID | NCT05626413 on ClinicalTrials.gov |
What this trial studies
This observational project aims to collect demographic, laboratory, and clinical data from diabetes patients in the Silesian region of Poland to predict cardiovascular disease and related events. The study will follow hospitalized patients for 10 years, with annual telephone contact post-discharge to gather information on new cardiovascular events. Additionally, patients from outpatient clinics will undergo various assessments, including vitamin D levels and vascular examinations. A machine learning approach will be utilized to identify high-risk patients based on easily obtainable clinical parameters.
Who should consider this trial
Good fit: Ideal candidates include individuals with type 1 or type 2 diabetes who are either hospitalized or receiving outpatient care in the Silesian region.
Not a fit: Patients with types of diabetes other than type 1 or type 2, or those with severe comorbidities like terminal cancer or end-stage renal disease, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance early identification and management of cardiovascular risks in diabetes patients.
How similar studies have performed: While this approach is observational and utilizes machine learning, similar studies have shown promise in identifying cardiovascular risks in diabetes patients.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Zabrze
- Department of Internal Diseases, Diabetology and Nephrology — Zabrze, Poland (Recruiting)
Study contacts
- Principal investigator: Katarzyna Nabrdalik, PhD,prof. — Medical University of Silesia
- Study coordinator: Katarzyna Nabrdalik, PhD, prof.
- Email: knabrdalik@sum.edu.pl
- Phone: 0048697592954
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.