Differentiating heart disease in autoimmune vs. type 2 diabetes
Official title: Differentiating Heart Disease Between Adult-onset Autoimmune and Type 2 Diabetes
Run by University of Roma La Sapienza · NCT07911007 · Data updated 2026-11-12
This study tests whether adult-onset autoimmune diabetes (AID/LADA) and type 2 diabetes (T2D) differ in how diabetic heart disease develops, using advanced heart imaging in people with AID, T2D, and healthy controls.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 30 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | University of Roma La Sapienza Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Rome, Roma) |
| Status | Recruiting |
| Started | June 20, 2024 |
| Main results expected | March 2029 |
| Study ends | March 2029 |
| Registry record updated | November 2, 2026 |
| Trial ID | NCT07911007 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults over 30 with LADA/AID or T2D for more than 12 months who are willing to undergo imaging and participate in autonomic assessments.
✕Probably not a fit
Patients with active cardiac disease or contraindications to MRI may not benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Researchers will compare diabetic heart disease across adults with AID/LADA, T2D, and non-diabetic controls who share similar cardiovascular risk factors. They will use advanced echocardiography and cardiac magnetic resonance to assess heart structure and function, and relate these findings to autonomic function and biomarkers. The study aims to map how immune-related diabetes and metabolic diabetes contribute to heart disease. Participants include adults with AID/LADA or T2D for at least a year, plus healthy controls over 30, all without major cardiac contraindications. Cardiac MRI is the primary imaging modality, with careful screening for other heart conditions.
Why it matters
Potential benefit: If successful, the study could clarify differential pathways of heart disease in autoimmune vs. metabolic diabetes, informing tailored monitoring and management.
How similar studies have gone: Previous work suggests imaging can reveal distinct heart changes in diabetes, but direct comparisons between AID and T2D are limited or novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * cardiac magnetic resonance contraindications * positive history of acute CV disease * cardiomyopathies other than diabetic cardiomyopathy * constrictive pericarditis * cardiac tumor * severe valve disease * active neoplastic disease on ongoing chemotherapy or chest radiotherapy
Where it's running
-
Policlinico Umberto I
Rome, Roma, Italy Recruiting
Study contacts
- Study coordinator: Ernesto Maddaloni, MD
- Email: ernesto.maddaloni@uniroma1.it
- Phone: +39 0649970952
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.