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

NCT ID: NCT06290544

Last Updated: 2024-03-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-29
• Study Completion Date: 2026-07-31

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.

Conditions

Diabetes Mellitus, Type 1; Cardiovascular Diseases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Single arm study

Subjects with type 1 diabetes mellitus who meet all the inclusion and none exclusion criteria

Group Type: OTHER

Standard of care plus additional examinations

Intervention Type: 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

Interventions

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centro Cardiologico Monzino

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stefano Genovese, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Centro Cardiologico Monzino

Locations

IRCCS Centro Cardiologico Monzino

Milan, , Italy

Site Status: RECRUITING

Policlinico di Monza

Monza, , Italy

Site Status: NOT_YET_RECRUITING

Countries

Italy

Central Contacts

Stefano Genovese, MD

Role: CONTACT

stefano.genovese@cardiologicomonzino.it

+390258002327

Maurizio Rondinelli, MD

Role: CONTACT

maurizio.rondinelli@cardiologicomonzino.it

+390258002040

Facility Contacts

Stefano Genovese, MD

Role: primary

stefano.genovese@cardiologicomonzino.it

0258002327

Gianluca Perseghin, MD

Role: primary

gianluca.perseghin@policlinicodimonza.it

+390392810430

Other Identifiers

CCM 1552

Identifier Type: -

Identifier Source: org_study_id