Clinical trial NCT06290544: Cardiovascular Risk Assessment in a Cohort of Italian Patients With Type 1 Diabetes Mellitus (CARDT1)
Official title: Cardiovascular Risk Assessment in a Cohort of Italian Patients With Type 1 Diabetes Mellitus - CARDT1
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Cardiovascular Diseases
Keywords: Diabetes
Diabetes Mellitus, Type 1
Cardiovascular risk
Cardiovascular Diseases
Lead sponsor: Centro Cardiologico Monzino
Sponsor class: OTHER
First posted: 2024-03-04
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective collection of data with diagnostic procedures different from standard clinical care in a specific cohort of patients.
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of type 1 diabetes mellitus.
* Age ≥ 18 years.
* Signed Informed consent

Exclusion Criteria:

* Age \< 18 years.
* Pregnancy in progress.
* Type 2 diabetes mellitus.
* Secondary diabetes

Primary outcomes:
measure: Stratify cohort of type 1 diabetes patient according to ESC/EASD 2019 guidelines.
timeFrame: 5 years
measure: Stratify cohort of type 1 diabetes patient according to the Steno Type 1 Risk Engine (ST1RE).
timeFrame: 5 years
measure: Prevalence of cardiovascular disease in type 1 diabetes patients
timeFrame: 5 years
Secondary outcomes:
measure: Prevalence of diabetic retinopathy
timeFrame: 5 years
measure: Prevalence of diabetic nephropathy
timeFrame: 5 years
measure: Prevalence of diabetic neuropathy
timeFrame: 5 years
measure: CT-derived calcium score
timeFrame: 5 years
measure: Carotid intima-media thickness
timeFrame: 5 years
measure: Prevalence of endothelial dysfuntion (evaluated using peripheral arterial tone detection method)
timeFrame: 5 years
measure: Stratify type 1 patient cohort by Food Frequency Questionnaire (FFQ)
timeFrame: At enrollment
measure: Stratify type 1 patient cohort by the Mediterranean Diet Adherence Screener score (MEDAS)
timeFrame: At enrollment
measure: Stratify type 1 patient cohort by psychological profiles using psychological validated questionnaires.
timeFrame: 5 years
measure: Stratify type 1 patient cohort by lipid profile
timeFrame: 5 years
measure: Stratify type 1 patient by glucose control using HbA1c and Ambulatory Glucose Profile metrics.
timeFrame: 5 years
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Centro Cardiologico Monzino
city: Monza
country: Italy
facility: Policlinico di Monza
Study officials:
affiliation: IRCCS Centro Cardiologico Monzino
name: Stefano Genovese, MD
role: PRINCIPAL_INVESTIGATOR
References: