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This is a multicenter prospective collection of data with diagnostic procedures different from standard clinical care in a specific cohort of patients, aimed to evaluate cardiovascular risk stratification with the European Society of Cardiology (ESC)/European Association for the Study of Diabetes (EASD) guidelines and "The Steno Type 1 Risk Engine" algorithm. The correlation between CVD risk, atherosclerosis, and microvascular complications of diabetes (retinopathy, nephropathy, and neuropathy) will then be evaluated, and the impact of glycemic variability and other glucose metrics on vascular damage will be characterized. The investigators plan to enroll at least 200 consecutive type 1 diabetes mellitus (T1DM) patients who meet all the inclusion criteria and none of exclusion criteria.
Patients with type 1 diabetes mellitus will be identified in the electronic medical records, and their clinical, anthropometric, and laboratory data, including markers of glycemic variability and other blood glucose metrics, will be collected. Cardiovascular risk will then be assessed using the stratification proposed by ESC/EASD and The Steno Type 1 Risk Engine.
As suggested by the guidelines, according to cardiovascular risk, participants will perform a coronary CT scan in order to investigate coronary anatomy, to study the atherosclerotic plaque morphology, to assess high-risk plaque characteristics, and in case of obstructive coronary artery disease, to investigate myocardial perfusion by adenosine infusion to assess both ischemia and microcirculation dysfunction. Noninvasive B-mode ultrasonography of the supra-aortic trunks will assess for signs of carotid atherosclerosis (i.e., carotid intima media thickness - c-IMT - and carotid plaques). Ankle-arm index (ABI), a noninvasive cardiovascular bio-marker, will provide information on peripheral arterial disease. Endothelial function will be also assessed using the ENDO-PAT 2000 instrument which measures endothelial dysfunction with a peripheral arterial tone detection method.
For the purpose of assessing participants' nutritional habits, participants will be asked to complete the Food Frequency Questionnaire (FFQ) the week prior the visit; once the FFQ will be completed an interview with the nutritionist will be scheduled in order to review and to ascertain its completeness; in addition, the PREDIMED questionnaire for calculating the Mediterranean Diet Adherence Screener score (MEDAS) will be administered to assess adherence to the Mediterranean diet.
An interview with the psychologist will be planned. During that visit the participant will receive information about the rationale of the study regarding psychological aspects, the questionnaires that will be administered and how to fill them out correctly online via the Qualtrics EU platform. The Iowa Gambling Task (IGT) test will then be administered.
Finally, biological samples will be collected for future genomic and epigenetic analyses associated with different cardiovascular disease (CVD) phenotypes and outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm study | Other | Subjects with type 1 diabetes mellitus who meet all the inclusion and none exclusion criteria |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard of care plus additional examinations | Other | The patient will undergo good clinical practice examinations according to guidelines plus The patient will undergo to the evaluation of endothelial dysfunction with ENDOPAT 2000 and whole blood sampling for future omics studies |
| Measure | Description | Time Frame |
|---|---|---|
| Stratify cohort of type 1 diabetes patient according to ESC/EASD 2019 guidelines. | Evaluation of cardiovascular risk class for type 1 diabetic patients using ESC/EASD stratification according to disease duration | 5 years |
| Stratify cohort of type 1 diabetes patient according to the Steno Type 1 Risk Engine (ST1RE). | Evaluation of cardiovascular risk class for type 1 diabetic patients using The Steno Type 1 Risk Engine algorithm | 5 years |
| Prevalence of cardiovascular disease in type 1 diabetes patients | Prevalence of cardiovascular disease in T1DM cohort defined as one of the following:
| 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of diabetic retinopathy | Prevalence of diabetic retinopathy | 5 years |
| Prevalence of diabetic nephropathy | Prevalence of diabetic nephropathy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stefano Genovese, MD | Contact | +390258002327 | stefano.genovese@cardiologicomonzino.it | |
| Maurizio Rondinelli, MD | Contact | +390258002040 | maurizio.rondinelli@cardiologicomonzino.it |
| Name | Affiliation | Role |
|---|---|---|
| Stefano Genovese, MD | IRCCS Centro Cardiologico Monzino | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Centro Cardiologico Monzino | Recruiting | Milan | 20138 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42277803 | Derived | Molinari C, Galotta A, Mushtaq S, Frigerio B, Vavassori C, Rondinelli M, Cosentino N, Romandini A, Chiesa M, Vinci MC, Colombo GI, Baldassarre D, Pontone G, Bonomi A, Genovese S. Predicting subclinical atherosclerosis in adults with type 1 diabetes using cardiovascular risk models: a cross-sectional study from Italy. Cardiovasc Diabetol. 2026 Jun 11. doi: 10.1186/s12933-026-03245-6. Online ahead of print. |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D002318 | Cardiovascular Diseases |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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Prospective collection of data with diagnostic procedures different from standard clinical care in a specific cohort of patients.
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|
| 5 years |
| Prevalence of diabetic neuropathy | Prevalence of diabetic neuropathy | 5 years |
| CT-derived calcium score | CT-derived calcium score | 5 years |
| Carotid intima-media thickness | Carotid intima-media thickness | 5 years |
| Prevalence of endothelial dysfuntion (evaluated using peripheral arterial tone detection method) | Prevalence of endothelial dysfuntion (evaluated using peripheral arterial tone detection method) | 5 years |
| Stratify type 1 patient cohort by Food Frequency Questionnaire (FFQ) | Stratify type 1 patient cohort by Food Frequency Questionnaire (FFQ) | At enrollment |
| Stratify type 1 patient cohort by the Mediterranean Diet Adherence Screener score (MEDAS) | Stratify type 1 patient cohort by the Mediterranean Diet Adherence Screener score (MEDAS) | At enrollment |
| Stratify type 1 patient cohort by psychological profiles using psychological validated questionnaires. | Stratify type 1 patient cohort by psychological profiles using psychological validated questionnaires. | 5 years |
| Stratify type 1 patient cohort by lipid profile | Stratify type 1 patient cohort by lipid profile | 5 years |
| Stratify type 1 patient by glucose control using HbA1c and Ambulatory Glucose Profile metrics. | Stratify type 1 patient by glucose control using HbA1c and Ambulatory Glucose Profile metrics. | 5 years |
| Policlinico di Monza | Not yet recruiting | Monza | 20900 | Italy |
|
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |