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RECRUITING
NCT07911007
NA

Differentiating Heart Disease Between Adult-onset Autoimmune and Type 2 Diabetes

Sponsor: University of Roma La Sapienza

View on ClinicalTrials.gov

Summary

Background: The study of factors associated with diabetic heart disease (DHD), the leading cause of mortality in diabetes, represents an unmet need. Autoimmune diabetes in adults (AID) and type 2 diabetes (T2D) differ in pathophysiology, vascular complications, and autonomic impairment, with significant implications for DHD, which results from a complex interplay among coronary micro- and macro-vascular circulation, neuro-immune control, and myocardial damage. Objective: To characterize the complexity of DHD and its determinants by comparing AID and T2D. Methods: DHD will be studied in individuals with AID, T2D, and healthy controls matched for cardiovascular risk factors. Advanced echocardiography and cardiovascular magnetic resonance will allow high-quality assessment of the different components of DHD (such as cardiac geometry, performance, and contraction). To identify the determinants of DHD, cardiac study results will be correlated with autonomic dysfunction tests, markers of small fiber neuropathy, and laboratory assessments of metabolic alterations, cardiac autoimmunity, and the inflammasome. Furthermore, genetic susceptibility to autoimmune diabetes and pancreatic autoimmunity will also be evaluated and correlated with DHD

Key Details

Gender

All

Age Range

30 Years - Any

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2024-06-20

Completion Date

2029-03

Last Updated

2026-11-02

Healthy Volunteers

Yes

Interventions

DIAGNOSTIC_TEST

Cardiac Magnetic Resonance

Cardiac Magnetic Resonance is an imaging technique for the assessment of the function and structure of the CV system, with high accuracy and reproducibility. Further, CMR enables to non-invasively evaluate coronary microvascular circulation and tissue characterizing the myocardium

Locations (1)

Policlinico Umberto I

Rome, Roma, Italy