Diabetes MellitusNCT05626413
Cardiovascular Disease in Patients With Diabetes: The Silesia Diabetes-Heart Project
An observational study of Diabetes Mellitus, run by Medical University of Silesia at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus
- How many people
- 4,000 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jan 2015to 31 Jan 2026
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients hospitalized in diabetology ward in Zabrze. Patients treated in outpatient diabetology clinics in Silesia region.
Who may be able to join
- 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
Who cannot join
- 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.
- For the subgroup of patients recruited form outpatient diabetology clinics:
- Lack of an informed consent
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Department of Internal Diseases, Diabetology and Nephrology
Zabrze, 41-800
Hanna Kwiendacz, MD,PhD, 0048509774849, hkwiendacz@sum.edu.pl
Katarzyna Nabrdalik, MD,PhD,prof, 0048697592954, knabrdalik@sum.edu.pl
About this study
Official title: Cardiovascular Disease and Diabetes in Silesian Patients
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.
Read the 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.
- Conditions
- Diabetes Mellitus
- Keywords
- Cardiovascular disease, Diabetes mellitus
- Medical subject headings
- Diabetes Mellitus, Cardiovascular Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
The risk of cardiovascular disease and events among patients with diabetes
To predict the risk of cardiovascular disease and events among patients with diabetes using machine learning approach
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2022
- Study start1 Jan 2015
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Medical University of Silesia
- Sponsor type
- University, hospital or other
- Collaborators
- Silesian University of Technology, Liverpool Heart and Chest Hospital NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Katarzyna Nabrdalik, PhD,prof., Principal investigator, Medical University of Silesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05626413
- Sponsor's protocol ID
- Silesia Diabetes-Heart Project
- Status last verified
- Sep 2023
- First submitted
- 15 Nov 2022
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Janota-Sosinska O, Yu Q, Irlik K, Kwiendacz H, Wlosowicz-Momot A, Pabis P, Wojcik W, Olejarz A, Piasnik J, Alam U, Zheng Y, Gumprecht J, Lip GYH, Nabrdalik K. Deep learning analysis of ECGs detects Cardiovascular-Kidney-Metabolic syndrome burden in people with diabetes: a report from the Silesia Diabetes-Heart Project. Cardiovasc Diabetol. 2026 Jun 29. doi: 10.1186/s12933-026-03246-5. Online ahead of print.
PubMed 42374510Janota O, Mantovani M, Kwiendacz H, Irlik K, Bucci T, Lam SHM, Huang B, Alam U, Boriani G, Hendel M, Piasnik J, Olejarz A, Wlosowicz A, Pabis P, Wojcik W, Gumprecht J, Lip GYH, Nabrdalik K. Metabolically "extremely unhealthy" obese and non-obese people with diabetes and the risk of cardiovascular adverse events: the Silesia Diabetes - Heart Project. Cardiovasc Diabetol. 2024 Sep 3;23(1):326. doi: 10.1186/s12933-024-02420-x.
PubMed 39227929Nabrdalik K, Irlik K, Meng Y, Kwiendacz H, Piasnik J, Hendel M, Ignacy P, Kulpa J, Kegler K, Herba M, Boczek S, Hashim EB, Gao Z, Gumprecht J, Zheng Y, Lip GYH, Alam U. Artificial intelligence-based classification of cardiac autonomic neuropathy from retinal fundus images in patients with diabetes: The Silesia Diabetes Heart Study. Cardiovasc Diabetol. 2024 Aug 10;23(1):296. doi: 10.1186/s12933-024-02367-z.
PubMed 39127709Irlik K, Aldosari H, Hendel M, Kwiendacz H, Piasnik J, Kulpa J, Ignacy P, Boczek S, Herba M, Kegler K, Coenen F, Gumprecht J, Zheng Y, Lip GYH, Alam U, Nabrdalik K. Artificial intelligence-enhanced electrocardiogram analysis for identifying cardiac autonomic neuropathy in patients with diabetes. Diabetes Obes Metab. 2024 Jul;26(7):2624-2633. doi: 10.1111/dom.15578. Epub 2024 Apr 11.
PubMed 38603589Nabrdalik K, Kwiendacz H, Irlik K, Hendel M, Drozdz K, Wijata AM, Nalepa J, Janota O, Wojcik W, Gumprecht J, Lip GYH. Machine learning identification of risk factors for heart failure in patients with diabetes mellitus with metabolic dysfunction associated steatotic liver disease (MASLD): the Silesia Diabetes-Heart Project. Cardiovasc Diabetol. 2023 Nov 20;22(1):318. doi: 10.1186/s12933-023-02014-z.
PubMed 37985994
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Disease and Diabetes in Silesian Patients
- ClinicalTrials.gov ID
- NCT05626413
- Acronym / sponsor ID
- Silesia Diabetes-Heart Project
- Conditions
- Diabetes Mellitus
- Keywords
- Cardiovascular disease, Diabetes mellitus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Medical University of SilesiaUniversity, hospital or other
- Collaborators
- Silesian University of Technology, Liverpool Heart and Chest Hospital NHS Foundation Trust
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 23 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalized in diabetology ward in Zabrze. Patients treated in outpatient diabetology clinics in Silesia region.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (13 listed)
- For the group of hospitalized patients:
- For the subgroup of patients recruited form outpatient diabetology clinics:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
- Derived from this study: PubMed 42374510Janota-Sosinska O, Yu Q, Irlik K, Kwiendacz H, Wlosowicz-Momot A, Pabis P, Wojcik W, Olejarz A, Piasnik J, Alam U, Zheng Y, Gumprecht J, Lip GYH, Nabrdalik K. Deep learning analysis of ECGs detects Cardiovascular-Kidney-Metabolic syndrome burden in people with diabetes: a report from the Silesia Diabetes-Heart Project. Cardiovasc Diabetol. 2026 Jun 29. doi: 10.1186/s12933-026-03246-5. Online ahead of print.
- Derived from this study: PubMed 39227929Janota O, Mantovani M, Kwiendacz H, Irlik K, Bucci T, Lam SHM, Huang B, Alam U, Boriani G, Hendel M, Piasnik J, Olejarz A, Wlosowicz A, Pabis P, Wojcik W, Gumprecht J, Lip GYH, Nabrdalik K. Metabolically "extremely unhealthy" obese and non-obese people with diabetes and the risk of cardiovascular adverse events: the Silesia Diabetes - Heart Project. Cardiovasc Diabetol. 2024 Sep 3;23(1):326. doi: 10.1186/s12933-024-02420-x.
- Derived from this study: PubMed 39127709Nabrdalik K, Irlik K, Meng Y, Kwiendacz H, Piasnik J, Hendel M, Ignacy P, Kulpa J, Kegler K, Herba M, Boczek S, Hashim EB, Gao Z, Gumprecht J, Zheng Y, Lip GYH, Alam U. Artificial intelligence-based classification of cardiac autonomic neuropathy from retinal fundus images in patients with diabetes: The Silesia Diabetes Heart Study. Cardiovasc Diabetol. 2024 Aug 10;23(1):296. doi: 10.1186/s12933-024-02367-z.
- Derived from this study: PubMed 38603589Irlik K, Aldosari H, Hendel M, Kwiendacz H, Piasnik J, Kulpa J, Ignacy P, Boczek S, Herba M, Kegler K, Coenen F, Gumprecht J, Zheng Y, Lip GYH, Alam U, Nabrdalik K. Artificial intelligence-enhanced electrocardiogram analysis for identifying cardiac autonomic neuropathy in patients with diabetes. Diabetes Obes Metab. 2024 Jul;26(7):2624-2633. doi: 10.1111/dom.15578. Epub 2024 Apr 11.
- Derived from this study: PubMed 37985994Nabrdalik K, Kwiendacz H, Irlik K, Hendel M, Drozdz K, Wijata AM, Nalepa J, Janota O, Wojcik W, Gumprecht J, Lip GYH. Machine learning identification of risk factors for heart failure in patients with diabetes mellitus with metabolic dysfunction associated steatotic liver disease (MASLD): the Silesia Diabetes-Heart Project. Cardiovasc Diabetol. 2023 Nov 20;22(1):318. doi: 10.1186/s12933-023-02014-z.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katarzyna Nabrdalik, PhD,prof. principal investigator
Medical University of Silesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, run by Medical University of Silesia at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Katarzyna Nabrdalik, PhD, prof. (0048697592954, knabrdalik@sum.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The risk of cardiovascular disease and events among patients with diabetes (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05626413, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2024.