Comparing Heart Disease in Adults With Autoimmune Diabetes and Type 2 Diabetes
Compares heart changes in adults with autoimmune diabetes, type 2 diabetes, and healthy adults.
Plain-language title generated from the registry record
Registry title: Differentiating Heart Disease Between Adult-onset Autoimmune and Type 2 Diabetes
Key facts
- Where
- Rome, ItalySee the site
Where in Italy
- Policlinico Umberto IRome, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Roma La Sapienza
- Trial code
- NCT07911007
- Record updated
- 2 November 2026
- Original description
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.Read full original descriptionShow less
Differentiating Heart Disease Between Adult-onset Autoimmune and Type 2 Diabetes
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
Inclusion: for people with LADA:; age at diabetes diagnosis >30years; insulin independence for at least 6 months after DM diagnosis and presence of any islet Ab; diabetes duration >12 months; willingness to participate in the study; for participants with T2D:; diagnosis of T2D made according to the ADA criteria; diabetes duration >12 months; willingness to participate in the study; for healthy controls:; age >30 years; no previous diagnosis of any form of diabetes; willingness to participate in the study.
Exclusion: cardiac magnetic resonance contraindications; positive history of acute CV disease; cardiac tumor; severe valve disease; active neoplastic disease on ongoing chemotherapy or chest radiotherapy; cardiomyopathies other than diabetic cardiomyopathy; constrictive pericarditis.