NCT07911007Recruiting
Differentiating Heart Disease Between Adult-onset Autoimmune and Type 2 Diabetes
Source: ClinicalTrials.gov · Last updated 2 Nov 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 23 Oct 2026
- Start date
- 20 Jun 2024
- Primary completion date
- 31 Mar 2029
- Lead sponsor
- University of Roma La Sapienza
- Diseases
- Type 1 diabetes, Type 2 diabetes
- NCT number
- NCT07911007
What you commit to
- Study type: Interventional
- Planned participants: 200
- From 20 Jun 2024 to the primary completion date, 31 Mar 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- cardiac magnetic resonance contraindications
- positive history of acute CV disease
- cardiac tumor
- severe valve disease
- active neoplastic disease on ongoing chemotherapy or chest radiotherapy
Other
- cardiomyopathies other than diabetic cardiomyopathy
- constrictive pericarditis
Who the study is looking for
- 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
Age in the registry: 30 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Policlinico Umberto I Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.