Cardiovascular Risk Assessment in a Cohort of Italian Patients With Type 1 Diabetes Mellitus (CARDT1) (CARDT1)

Cardiovascular Risk Assessment in a Cohort of Italian Patients With Type 1 Diabetes Mellitus - CARDT1

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases; Diabetes Mellitus, Type 1
• Intervention / Treatment: Other: Standard of care plus additional examinations

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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stefano Genovese, MD; Phone Number: +390258002327; Email: stefano.genovese@cardiologicomonzino.it
• Study Contact Backup: Name: Maurizio Rondinelli, MD; Phone Number: +390258002040; Email: maurizio.rondinelli@cardiologicomonzino.it

Study Locations

• Italy
  • Milan, Italy, 20138
    • Recruiting
    • IRCCS Centro Cardiologico Monzino
    • Contact: Stefano Genovese, MD; Phone Number: 0258002327; Email: stefano.genovese@cardiologicomonzino.it
  • Monza, Italy, 20900
    • Not yet recruiting
    • Policlinico di Monza
    • Contact: Gianluca Perseghin, MD; Phone Number: +390392810430; Email: gianluca.perseghin@policlinicodimonza.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Single arm study; Subjects with type 1 diabetes mellitus who meet all the inclusion and none exclusion criteria	Other: Standard of care plus additional examinations; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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: acute mycardial infarction; ischemic stroke; peripheral artery disease; coronary, carotid or peripheral artery revascularization; presence of clinically significant stenosis in coronary CT and/or in carotid ultrasound assessment.	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of diabetic retinopathy	Prevalence of diabetic retinopathy	5 years
Prevalence of diabetic nephropathy	Prevalence of diabetic nephropathy	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

Collaborators and Investigators

• Sponsor: Centro Cardiologico Monzino
• Investigators: Principal Investigator: Stefano Genovese, MD, IRCCS Centro Cardiologico Monzino

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2021
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: March 30, 2023
• First Submitted That Met QC Criteria: February 26, 2024
• First Posted (Estimated): March 4, 2024

Study Record Updates

• Last Update Posted (Estimated): March 4, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Diabetes; Cardiovascular Diseases; Cardiovascular risk; Diabetes Mellitus, Type 1
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Cardiovascular Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: CCM 1552

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No