Diabetes Mellitus, Type 1CARDT1NCT06290544
Cardiovascular Risk Assessment in a Cohort of Italian Patients With Type 1 Diabetes Mellitus (CARDT1)
A study of Diabetes Mellitus, Type 1 and Cardiovascular Diseases, run by Centro Cardiologico Monzino at 2 sites in Italy.
Trial summary
This is a multicenter prospective collection of data with diagnostic procedures different from standard clinical care in a specific cohort of patients, aimed to evaluate cardiovascular risk stratification with the European Society of Cardiology (ESC)/European Association for the Study of Diabetes (EASD) guidelines and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 1, Cardiovascular Diseases
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesItaly
- Study dates
- 29 Nov 2021to Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of type 1 diabetes mellitus.
- Age ≥ 18 years.
- Signed Informed consent
Who cannot join
- Age < 18 years.
- Pregnancy in progress.
- Type 2 diabetes mellitus.
- Secondary diabetes
Trial locations and contacts
2 sites in 1 country.
Italy2 sites, 2 recruiting
- Recruiting
IRCCS Centro Cardiologico Monzino
Milan, 20138
Stefano Genovese, MD, 0258002327, stefano.genovese@cardiologicomonzino.it
- Not yet recruiting
Policlinico di Monza
Monza, 20900
Gianluca Perseghin, MD, +390392810430, gianluca.perseghin@policlinicodimonza.it
About this study
Official title: Cardiovascular Risk Assessment in a Cohort of Italian Patients With Type 1 Diabetes Mellitus - CARDT1
This is a multicenter prospective collection of data with diagnostic procedures different from standard clinical care in a specific cohort of patients, aimed to evaluate cardiovascular risk stratification with the European Society of Cardiology (ESC)/European Association for the Study of Diabetes (EASD) guidelines and "The Steno Type 1 Risk Engine" algorithm. The correlation between CVD risk, atherosclerosis, and microvascular complications of diabetes (retinopathy, nephropathy, and neuropathy) will then be evaluated, and the impact of glycemic variability and other glucose metrics on vascular damage will be characterized. The investigators plan to enroll at least 200 consecutive type 1 diabetes mellitus (T1DM) patients who meet all the inclusion criteria and none of exclusion criteria.
Read the detailed description
Patients with type 1 diabetes mellitus will be identified in the electronic medical records, and their clinical, anthropometric, and laboratory data, including markers of glycemic variability and other blood glucose metrics, will be collected. Cardiovascular risk will then be assessed using the stratification proposed by ESC/EASD and The Steno Type 1 Risk Engine.
As suggested by the guidelines, according to cardiovascular risk, participants will perform a coronary CT scan in order to investigate coronary anatomy, to study the atherosclerotic plaque morphology, to assess high-risk plaque characteristics, and in case of obstructive coronary artery disease, to investigate myocardial perfusion by adenosine infusion to assess both ischemia and microcirculation dysfunction. Noninvasive B-mode ultrasonography of the supra-aortic trunks will assess for signs of carotid atherosclerosis (i.e., carotid intima media thickness - c-IMT - and carotid plaques). Ankle-arm index (ABI), a noninvasive cardiovascular bio-marker, will provide information on peripheral arterial disease. Endothelial function will be also assessed using the ENDO-PAT 2000 instrument which measures endothelial dysfunction with a peripheral arterial tone detection method.
For the purpose of assessing participants' nutritional habits, participants will be asked to complete the Food Frequency Questionnaire (FFQ) the week prior the visit; once the FFQ will be completed an interview with the nutritionist will be scheduled in order to review and to ascertain its completeness; in addition, the PREDIMED questionnaire for calculating the Mediterranean Diet Adherence Screener score (MEDAS) will be administered to assess adherence to the Mediterranean diet.
An interview with the psychologist will be planned. During that visit the participant will receive information about the rationale of the study regarding psychological aspects, the questionnaires that will be administered and how to fill them out correctly online via the Qualtrics EU platform. The Iowa Gambling Task (IGT) test will then be administered.
Finally, biological samples will be collected for future genomic and epigenetic analyses associated with different cardiovascular disease (CVD) phenotypes and outcomes.
- Conditions
- Diabetes Mellitus, Type 1, Cardiovascular Diseases
- Being tested
- Standard of care plus additional examinations
- Keywords
- Diabetes, Diabetes Mellitus, Type 1, Cardiovascular risk, Cardiovascular Diseases
- Medical subject headings
- Diabetes Mellitus, Type 1, Cardiovascular Diseases, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of care plus additional examinationsOther
The patient will undergo good clinical practice examinations according to guidelines plus The patient will undergo to the evaluation of endothelial dysfunction with ENDOPAT 2000 and whole blood sampling for future omics studies
| Study group | Role | What they receive |
|---|---|---|
| Single arm study | Other | Subjects with type 1 diabetes mellitus who meet all the inclusion and none exclusion criteria Receives: Other: Standard of care plus additional examinations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stratify cohort of type 1 diabetes patient according to ESC/EASD 2019 guidelines.
Evaluation of cardiovascular risk class for type 1 diabetic patients using ESC/EASD stratification according to disease duration
Measured: 5 years
Stratify cohort of type 1 diabetes patient according to the Steno Type 1 Risk Engine (ST1RE).
Evaluation of cardiovascular risk class for type 1 diabetic patients using The Steno Type 1 Risk Engine algorithm
Measured: 5 years
Prevalence of cardiovascular disease in type 1 diabetes patients
Prevalence of cardiovascular disease in T1DM cohort defined as one of the following:
- acute mycardial infarction
- ischemic stroke
- peripheral artery disease
- coronary, carotid or peripheral artery revascularization
- presence of clinically significant stenosis in coronary CT and/or in carotid ultrasound assessment.
Measured: 5 years
Secondary outcomes (11)
Prevalence of diabetic retinopathy
Prevalence of diabetic retinopathy
Measured: 5 years
Prevalence of diabetic nephropathy
Prevalence of diabetic nephropathy
Measured: 5 years
Prevalence of diabetic neuropathy
Prevalence of diabetic neuropathy
Measured: 5 years
CT-derived calcium score
CT-derived calcium score
Measured: 5 years
Carotid intima-media thickness
Carotid intima-media thickness
Measured: 5 years
Prevalence of endothelial dysfuntion (evaluated using peripheral arterial tone detection method)
Prevalence of endothelial dysfuntion (evaluated using peripheral arterial tone detection method)
Measured: 5 years
Stratify type 1 patient cohort by Food Frequency Questionnaire (FFQ)
Stratify type 1 patient cohort by Food Frequency Questionnaire (FFQ)
Measured: At enrollment
Stratify type 1 patient cohort by the Mediterranean Diet Adherence Screener score (MEDAS)
Stratify type 1 patient cohort by the Mediterranean Diet Adherence Screener score (MEDAS)
Measured: At enrollment
Stratify type 1 patient cohort by psychological profiles using psychological validated questionnaires.
Stratify type 1 patient cohort by psychological profiles using psychological validated questionnaires.
Measured: 5 years
Stratify type 1 patient cohort by lipid profile
Stratify type 1 patient cohort by lipid profile
Measured: 5 years
Stratify type 1 patient by glucose control using HbA1c and Ambulatory Glucose Profile metrics.
Stratify type 1 patient by glucose control using HbA1c and Ambulatory Glucose Profile metrics.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start29 Nov 2021
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective collection of data with diagnostic procedures different from standard clinical care in a specific cohort of patients.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Cardiologico Monzino
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stefano Genovese, MD, Principal investigator, IRCCS Centro Cardiologico Monzino
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06290544
- Sponsor's protocol ID
- CCM 1552
- Acronym
- CARDT1
- Status last verified
- Oct 2023
- First submitted
- 30 Mar 2023
- Last updated
- 4 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Molinari C, Galotta A, Mushtaq S, Frigerio B, Vavassori C, Rondinelli M, Cosentino N, Romandini A, Chiesa M, Vinci MC, Colombo GI, Baldassarre D, Pontone G, Bonomi A, Genovese S. Predicting subclinical atherosclerosis in adults with type 1 diabetes using cardiovascular risk models: a cross-sectional study from Italy. Cardiovasc Diabetol. 2026 Jun 11. doi: 10.1186/s12933-026-03245-6. Online ahead of print.
PubMed 42277803
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Risk Assessment in a Cohort of Italian Patients With Type 1 Diabetes Mellitus - CARDT1
- ClinicalTrials.gov ID
- NCT06290544
- Acronym / sponsor ID
- CARDT1 / CCM 1552
- Conditions
- Diabetes Mellitus, Type 1, Cardiovascular Diseases
- Keywords
- Diabetes, Diabetes Mellitus, Type 1, Cardiovascular risk, Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Centro Cardiologico MonzinoUniversity, hospital or other
- Study start
- 29 Nov 2021 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 4 Mar 2024 (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.
This is a multicenter prospective collection of data with diagnostic procedures different from standard clinical care in a specific cohort of patients, aimed to evaluate cardiovascular risk stratification with the European Society of Cardiology (ESC)/European Association for the Study of Diabetes (EASD) guidelines and "The Steno Type 1 Risk Engine" algorithm. The correlation between CVD risk, atherosclerosis, and microvascular complications of diabetes (retinopathy, nephropathy, and neuropathy) will then be evaluated, and the impact of glycemic variability and other glucose metrics on vascular damage will be characterized. The investigators plan to enroll at least 200 consecutive type 1 diabetes mellitus (T1DM) patients who meet all the inclusion criteria and none of exclusion criteria.
Detailed description
Patients with type 1 diabetes mellitus will be identified in the electronic medical records, and their clinical, anthropometric, and laboratory data, including markers of glycemic variability and other blood glucose metrics, will be collected. Cardiovascular risk will then be assessed using the stratification proposed by ESC/EASD and The Steno Type 1 Risk Engine.
As suggested by the guidelines, according to cardiovascular risk, participants will perform a coronary CT scan in order to investigate coronary anatomy, to study the atherosclerotic plaque morphology, to assess high-risk plaque characteristics, and in case of obstructive coronary artery disease, to investigate myocardial perfusion by adenosine infusion to assess both ischemia and microcirculation dysfunction. Noninvasive B-mode ultrasonography of the supra-aortic trunks will assess for signs of carotid atherosclerosis (i.e., carotid intima media thickness - c-IMT - and carotid plaques). Ankle-arm index (ABI), a noninvasive cardiovascular bio-marker, will provide information on peripheral arterial disease. Endothelial function will be also assessed using the ENDO-PAT 2000 instrument which measures endothelial dysfunction with a peripheral arterial tone detection method.
For the purpose of assessing participants' nutritional habits, participants will be asked to complete the Food Frequency Questionnaire (FFQ) the week prior the visit; once the FFQ will be completed an interview with the nutritionist will be scheduled in order to review and to ascertain its completeness; in addition, the PREDIMED questionnaire for calculating the Mediterranean Diet Adherence Screener score (MEDAS) will be administered to assess adherence to the Mediterranean diet.
An interview with the psychologist will be planned. During that visit the participant will receive information about the rationale of the study regarding psychological aspects, the questionnaires that will be administered and how to fill them out correctly online via the Qualtrics EU platform. The Iowa Gambling Task (IGT) test will then be administered.
Finally, biological samples will be collected for future genomic and epigenetic analyses associated with different cardiovascular disease (CVD) phenotypes and outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective collection of data with diagnostic procedures different from standard clinical care in a specific cohort of patients.
| Arm | Type | Receives |
|---|---|---|
| Single arm study | Other | Other: Standard of care plus additional examinationsSubjects with type 1 diabetes mellitus who meet all the inclusion and none exclusion criteria |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of type 1 diabetes mellitus.
- Age ≥ 18 years.
- Signed Informed consent
Key exclusion criteria (4 listed)
- Age < 18 years.
- Pregnancy in progress.
- Type 2 diabetes mellitus.
- Secondary diabetes
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 |
|---|---|---|
| Standard of care plus additional examinationsThe patient will undergo good clinical practice examinations according to guidelines plus The patient will undergo to the evaluation of endothelial dysfunction with ENDOPAT 2000 and whole blood sampling for future omics studies | Other | Single arm study |
Primary outcome
Stratify cohort of type 1 diabetes patient according to ESC/EASD 2019 guidelines.
Time frame: 5 years
Evaluation of cardiovascular risk class for type 1 diabetic patients using ESC/EASD stratification according to disease duration
Stratify cohort of type 1 diabetes patient according to the Steno Type 1 Risk Engine (ST1RE).
Time frame: 5 years
Evaluation of cardiovascular risk class for type 1 diabetic patients using The Steno Type 1 Risk Engine algorithm
Prevalence of cardiovascular disease in type 1 diabetes patients
Time frame: 5 years
Prevalence of cardiovascular disease in T1DM cohort defined as one of the following: * acute mycardial infarction * ischemic stroke * peripheral artery disease * coronary, carotid or peripheral artery revascularization * presence of clinically significant stenosis in coronary CT and/or in carotid ultrasound assessment.
11 secondary outcomes
Prevalence of diabetic retinopathy
Time frame: 5 years
Prevalence of diabetic nephropathy
Time frame: 5 years
Prevalence of diabetic neuropathy
Time frame: 5 years
CT-derived calcium score
Time frame: 5 years
Carotid intima-media thickness
Time frame: 5 years
Prevalence of endothelial dysfuntion (evaluated using peripheral arterial tone detection method)
Time frame: 5 years
Stratify type 1 patient cohort by Food Frequency Questionnaire (FFQ)
Time frame: At enrollment
Stratify type 1 patient cohort by the Mediterranean Diet Adherence Screener score (MEDAS)
Time frame: At enrollment
Stratify type 1 patient cohort by psychological profiles using psychological validated questionnaires.
Time frame: 5 years
Stratify type 1 patient cohort by lipid profile
Time frame: 5 years
Stratify type 1 patient by glucose control using HbA1c and Ambulatory Glucose Profile metrics.
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2024.
- Derived from this study: PubMed 42277803Molinari C, Galotta A, Mushtaq S, Frigerio B, Vavassori C, Rondinelli M, Cosentino N, Romandini A, Chiesa M, Vinci MC, Colombo GI, Baldassarre D, Pontone G, Bonomi A, Genovese S. Predicting subclinical atherosclerosis in adults with type 1 diabetes using cardiovascular risk models: a cross-sectional study from Italy. Cardiovasc Diabetol. 2026 Jun 11. doi: 10.1186/s12933-026-03245-6. Online ahead of print.
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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. This study is not recruiting at the moment.
Stefano Genovese, MD principal investigator
IRCCS Centro Cardiologico Monzino
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Diabetes Mellitus, Type 1 and Cardiovascular Diseases, run by Centro Cardiologico Monzino at 2 sites 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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 4 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stefano Genovese, MD (+390258002327, stefano.genovese@cardiologicomonzino.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stratify cohort of type 1 diabetes patient according to ESC/EASD 2019 guidelines. (time frame: 5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06290544, which also lists 1 linked publication.
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 4 Mar 2024.