An interventional study of Cardiac Magnetic Resonance in Diabete Mellitus, Autoimmune Diabetes and Latent Autoimmune Diabetes in Adult (LADA), sponsored by University of Roma La Sapienza. Recruiting at 1 site in Italy. Open to participants aged 30 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by University of Roma La Sapienza · Not applicable, Interventional, and Diagnostic
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
8,290 studies on the registry are indexed under Diabetes Mellitus; 1,077 are open to participants now.
This study's planned enrollment of 200 is above the median of 80 across 6,023 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →University of Roma La Sapienza is the lead sponsor of 398 studies on the registry; 56 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
for people with LADA:
for participants with T2D:
for healthy controls:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
People living with autoimmune diabetes in adults (LADA)
Diagnostic Test: Cardiac Magnetic Resonance
People living with type 2 diabetes
Diagnostic Test: Cardiac Magnetic Resonance
People without diabetes
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
Difference between LADA and T2D in the distribution in the identified clusters of diabetic heart disease
Cluster analysis based on measures of cardiac geometry and function derived from cardiac imaging will be used to define clusters of cardiac phenotypes. Differences in the distribution of groups in cardiac clusters will be tested
Time frame: Baseline, pre-procedure
Differences in circulating markers of metabolic and cardiovascular health between groups
Time frame: Baseline, pre-procedure
Relationship of the circulating markers of metabolic and cardiovascular health with cardiac structure and function evaluated by cardiac imaging
Time frame: Baseline, pre-procedure
Relationship between small nerve fibers damage with cardiac structure and function
Relationship between markers of small nerve fibers damage derived from corneal confocal microscopy and from cardiac autonomic reflex tests with cardiac structure and function evaluated by cardiac imaging
Time frame: Baseline, pre-procedure
Differences in cardiac autoimmunity between groups
Differences in the prevalence and levels of cardiac autoantibodies and in genetic predisposition to autoimmune diabetes between groups and their relationship with cardiac structure and function evaluated by cardiac imaging
Time frame: Baseline, pre-procedure
Differences in extracellular vescicles (EV) and markers of inflammasome activation between groups
Time frame: Baseline, pre-procedure
Relationship of different EV and inflammasome profiles with cardiac structure and function evaluated by cardiac imaging
Time frame: Baseline, pre-procedure
Longitudinal changes of cardiac contraction, geometry and coronary artery microcirculation, in relation to metabolic profile and inflammasome markers.
Time frame: Through study completion, an average of 2.5 years
Plan to share: Undecided
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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