Diabete MellitusHD DIABNCT07911007
Differentiating Heart Disease Between Adult-onset Autoimmune and Type 2 Diabetes
A study testing Cardiac Magnetic Resonance in people with Diabete Mellitus and Autoimmune Diabetes, run by University of Roma La Sapienza at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabete Mellitus, Autoimmune Diabetes, Latent Autoimmune Diabetes in Adult (LADA)
- What is being tested?
- Cardiac Magnetic Resonance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 20 Jun 2024to Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
Show all 13Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Policlinico Umberto I
Rome, Roma, 00161
Ernesto Maddaloni, MD, +39 0649970952, ernesto.maddaloni@uniroma1.it
Luca D'Onofrio, MD
About this study
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
- Conditions
- Diabete Mellitus, Autoimmune Diabetes, Latent Autoimmune Diabetes in Adult (LADA), Type 2 Diabetes, Heart Disease, Cardiometabolic Diseases
- Being tested
- Cardiac Magnetic Resonance
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Heart Diseases, Diabetic Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac Magnetic ResonanceDiagnostic test
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
| Study group | Role | What they receive |
|---|---|---|
| Latent Autoimmune Diabetes in Adults | Other | People living with autoimmune diabetes in adults (LADA) Receives: Diagnostic Test: Cardiac Magnetic Resonance |
| Type 2 Diabetes | Other | People living with type 2 diabetes Receives: Diagnostic Test: Cardiac Magnetic Resonance |
| Control | Other | People without diabetes Receives: Diagnostic Test: Cardiac Magnetic Resonance |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, pre-procedure
Secondary outcomes (4)
Differences in circulating markers of metabolic and cardiovascular health between groups
Measured: Baseline, pre-procedure
Relationship of the circulating markers of metabolic and cardiovascular health with cardiac structure and function evaluated by cardiac imaging
Measured: 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
Measured: 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
Measured: Baseline, pre-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start20 Jun 2024
- Primary completionMar 2029 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabete MellitusStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ernesto Maddaloni, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07911007
- Sponsor's protocol ID
- CUP B53C23004650001
- Other IDs
- FIS00001148
- Acronym
- HD DIAB
- Status last verified
- Oct 2026
- First submitted
- 23 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differentiating Heart Disease Between Adult-onset Autoimmune and Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT07911007
- Acronym / sponsor ID
- HD DIAB / CUP B53C23004650001
- Conditions
- Diabete Mellitus, Autoimmune Diabetes, Latent Autoimmune Diabetes in Adult (LADA), Type 2 Diabetes, Heart Disease, Cardiometabolic Diseases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- 20 Jun 2024 (actual)
- Primary completion
- Mar 2029 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 2 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Latent Autoimmune Diabetes in Adults | Other | Diagnostic Test: Cardiac Magnetic ResonancePeople living with autoimmune diabetes in adults (LADA) |
| Type 2 Diabetes | Other | Diagnostic Test: Cardiac Magnetic ResonancePeople living with type 2 diabetes |
| Control | Other | Diagnostic Test: Cardiac Magnetic ResonancePeople without diabetes |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- for people with LADA:
- for participants with T2D:
- for healthy controls:
Key exclusion criteria (7 listed)
- cardiac magnetic resonance contraindications
- positive history of acute CV disease
- cardiomyopathies other than diabetic cardiomyopathy
- constrictive pericarditis
- cardiac tumor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac Magnetic ResonanceCardiac 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 | Diagnostic test | Control, Latent Autoimmune Diabetes in Adults, Type 2 Diabetes |
Primary outcome
Difference between LADA and T2D in the distribution in the identified clusters of diabetic heart disease
Time frame: Baseline, pre-procedure
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
4 secondary outcomes
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
Time frame: Baseline, pre-procedure
Differences in cardiac autoimmunity between groups
Time frame: Baseline, pre-procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Diabete Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac Magnetic Resonance in people with Diabete Mellitus and Autoimmune Diabetes, run by University of Roma La Sapienza at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ernesto Maddaloni, MD (+39 0649970952, ernesto.maddaloni@uniroma1.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference between LADA and T2D in the distribution in the identified clusters of diabetic heart disease (time frame: Baseline, pre-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.