Diabetes Mellitus, Type 2NCT05915260
CMR in T2DM: The NSR Cohort
An observational study of Diabetes Mellitus, Type 2 and Diabetic Cardiomyopathies, run by Slagelse Hospital at 1 site in Denmark.
Trial summary
This study aims to investigate the myocardial phenotype of patients with type 2 diabetes. From 2016-2019 the investigators recruited a cohort of 296 subjects with type 2 diabetes. All subjects underwent clinical examinations including a gadolinium contrast cardiac MRI. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2, Diabetic Cardiomyopathies, Cardiovascular Magnetic Resonance Imaging
- What is being tested?
- All subjects will undergo cardiac magnetic resonance imaging with gadolinium contrast and with adenosine myocardial perfusion
- How many people
- 700 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Apr 2023to 31 Jan 2030
- Phase
- Observational
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: * Unable to give informed consent * Absolute contraindications to CMR * Severe claustrophobia * Type 1 diabetes mellitus * More than trivial paroxysmal atrial fibrillation, i.e. persistent or permanent atrial fibrillation * Women of childbearing potential not on acceptable contraception * Contraindications to adenosine, e.g. 2nd or 3rd degree AV-block, severe hypotension, long QT-syndrome, unstable angina pectoris, sinus node dysfunction, decompensated heart failure
Who may be able to join
- Few and simple, allowing for a broad cohort.
- Male or female fully capable of providing informed consent
- Informed consent
- Age 18-80 (both included)
- T2DM diagnosed at least 3 months prior to inclusion in the study
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site
Slagelse Hospital, department of cardiology and endocrinology, medicine 2
Slagelse, 4200
About this study
Official title: Cardiac Magnetic Resonance Imaging in Type 2 Diabetes Mellitus: The Næstved/Slagelse/Ringsted Cohort
This study aims to investigate the myocardial phenotype of patients with type 2 diabetes. From 2016-2019 the investigators recruited a cohort of 296 subjects with type 2 diabetes. All subjects underwent clinical examinations including a gadolinium contrast cardiac MRI.
The current study is a clinical follow-up study of the subjects, thus, the investigators will invite all participants to a reevaluation with cardiac MRI.
Read more
Additionally, the investigators will aim at recruiting additionally 400 patients with type 2 diabetes.
The aim it to characterize the phenotype of diabetic cardiomyopathy. Uniquely using cardiac MRI we can measure myocardial microvascular function, myocardial localised and diffuse fibrosis in addition to the quantification of myocardial structure and systolic and diastolic function.
- Conditions
- Diabetes Mellitus, Type 2, Diabetic Cardiomyopathies, Cardiovascular Magnetic Resonance Imaging, Coronary Microvascular Dysfunction, Myocardium; Fibrosis
- Being tested
- All subjects will undergo cardiac magnetic resonance imaging with gadolinium contrast and with adenosine myocardial perfusion
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetic Cardiomyopathies, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
All subjects will undergo cardiac magnetic resonance imaging with gadolinium contrast and with adenosine myocardial perfusionDiagnostic test
Also called Echocardiography, medical interview, general medical examination, BP, HR e.g., Examination for non cardiac complications to diabetes
This is a observational follow up study accordingly all subjects will undergo the same examinations
| Study group | Role | What they receive |
|---|---|---|
| Patients with type 2 diabetes | This group will be split up into different groups. DM2 with vs. without complications to diabetes DM2 with vs. without albuminuria/nephropathy or autonomic neuropathy or retinopathy or peripheral neuropathy or macrovascular angiopathy Receives: Diagnostic Test: All subjects will undergo cardiac magnetic resonance imaging with gadolinium contrast and with adenosine myocardial perfusion | |
| sex and age matched control subjects | Not described Receives: Diagnostic Test: All subjects will undergo cardiac magnetic resonance imaging with gadolinium contrast and with adenosine myocardial perfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association of myocardial microvascular function in patients with type 2 diabetes with MACE after 5 years
Myocardial microvascular function is measured by the myocardial perfusion ratio, quantified by cardiac MRI. MACE defined as CVD events (AMI, HF, stable angina, atrial fibrillation, ventricular arytmia), stroke, death
Measured: 5 years follow-up
Clinical factors associated with worsening of diabetic cardiomyopathy after 5 years
Clinical factors :Albuminuria, autonomic neuropathy, retinopathy, HbA1c, hs-CRP.
Signs of worsening af diabetic cardiomyopathy: Increased myocardial extracellular volume, decreased myocardial blood flow and myocardial perfusion reserve, decreased strain (GLS; GCS, GRS), increasing E/e´, increasing concentri remodeling index(LV mass / LV end-diastolic volume)
Measured: 5 years follow-up
Impact of myocardial perfusion and cardiac cardiac output on perfusion in other organs (kidney, spleen, liver) assed by gadolinium contrast magnetic resonance imaging
Myocardial perfusion measured by myocardial blood flow and myocardial perfusion ratio quantified by cardiac MRI.
Measured: Baseline and at 5 years follow-up
The association of pericardial- and epicardial fat with myocardial function and MACE after 5 year
Myocardial function: LVEF, LV strain (GLS, GCS, GRS), E/e´, myocardial extracellular volume, myocardial perfusion ratio.
MACE defined as CVD events (AMI, HF, stable angina, atrial fibrillation, ventricular arytmia), stroke, death
Measured: Baseline and at 5 years follow-up
Secondary outcomes (1)
Characterization of the progression of diabetic cardiomyopathy over 5 years, including LV+RV function, the coronary microvascular function, the coronary macrovascular function, fibrosis, aortic stiffness, per and epicardial fat, perfusion of other organs
Using multivariable regression including age, sex, smoking, Hypertension, HbA1c, CRP, blood pressure, albuminuria, autonomic neuropathy, retinopathy factors associated with either progression or regression of diabetic cardiomyopathy will be tested. Progression of diabetic cardiomyopathy will be defined as increasing myocardial extracellular volume, decreasing myocardial perfusion reserve, decreasing strain (GLS, GCS, GRS), increasing E/e´compared to baseline.
Measured: 5 years follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start1 Apr 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Slagelse Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Herlev Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05915260
- Sponsor's protocol ID
- SJ-992
- Status last verified
- Jun 2023
- First submitted
- 25 May 2023
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: On request and with the proper approvals
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Magnetic Resonance Imaging in Type 2 Diabetes Mellitus: The Næstved/Slagelse/Ringsted Cohort
- ClinicalTrials.gov ID
- NCT05915260
- Acronym / sponsor ID
- SJ-992
- Conditions
- Diabetes Mellitus, Type 2, Diabetic Cardiomyopathies, Cardiovascular Magnetic Resonance Imaging, Coronary Microvascular Dysfunction, Myocardium; Fibrosis
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Slagelse HospitalUniversity, hospital or other
- Collaborators
- Herlev Hospital
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Jan 2030 (estimated)
- First posted
- 22 Jun 2023 (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 study aims to investigate the myocardial phenotype of patients with type 2 diabetes. From 2016-2019 the investigators recruited a cohort of 296 subjects with type 2 diabetes. All subjects underwent clinical examinations including a gadolinium contrast cardiac MRI.
The current study is a clinical follow-up study of the subjects, thus, the investigators will invite all participants to a reevaluation with cardiac MRI.
Additionally, the investigators will aim at recruiting additionally 400 patients with type 2 diabetes.
The aim it to characterize the phenotype of diabetic cardiomyopathy. Uniquely using cardiac MRI we can measure myocardial microvascular function, myocardial localised and diffuse fibrosis in addition to the quantification of myocardial structure and systolic and diastolic function.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with type 2 diabetes | – | Diagnostic Test: All subjects will undergo cardiac magnetic resonance imaging with gadolinium contrast and with adenosine myocardial perfusionThis group will be split up into different groups. DM2 with vs. without complications to diabetes DM2 with vs. without albuminuria/nephropathy or autonomic neuropathy or retinopathy or peripheral neuropathy or macrovascular angiopathy |
| sex and age matched control subjects | – | Diagnostic Test: All subjects will undergo cardiac magnetic resonance imaging with gadolinium contrast and with adenosine myocardial perfusion |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- * Unable to give informed consent * Absolute contraindications to CMR * Severe claustrophobia * Type 1 diabetes mellitus * More than trivial paroxysmal atrial fibrillation, i.e. persistent or permanent atrial fibrillation * Women of childbearing potential not on acceptable contraception * Contraindications to adenosine, e.g. 2nd or 3rd degree AV-block, severe hypotension, long QT-syndrome, unstable angina pectoris, sinus node dysfunction, decompensated heart failure
Key inclusion criteria (5 listed)
- Few and simple, allowing for a broad cohort.
- Male or female fully capable of providing informed consent
- Informed consent
- Age 18-80 (both included)
- T2DM diagnosed at least 3 months prior to inclusion in the study
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| All subjects will undergo cardiac magnetic resonance imaging with gadolinium contrast and with adenosine myocardial perfusionAlso: Echocardiography, medical interview, general medical examination, BP, HR e.g., Examination for non cardiac complications to diabetesThis is a observational follow up study accordingly all subjects will undergo the same examinations | Diagnostic test | Patients with type 2 diabetes, sex and age matched control subjects |
Primary outcome
Association of myocardial microvascular function in patients with type 2 diabetes with MACE after 5 years
Time frame: 5 years follow-up
Myocardial microvascular function is measured by the myocardial perfusion ratio, quantified by cardiac MRI. MACE defined as CVD events (AMI, HF, stable angina, atrial fibrillation, ventricular arytmia), stroke, death
Clinical factors associated with worsening of diabetic cardiomyopathy after 5 years
Time frame: 5 years follow-up
Clinical factors :Albuminuria, autonomic neuropathy, retinopathy, HbA1c, hs-CRP. Signs of worsening af diabetic cardiomyopathy: Increased myocardial extracellular volume, decreased myocardial blood flow and myocardial perfusion reserve, decreased strain (GLS; GCS, GRS), increasing E/e´, increasing concentri remodeling index(LV mass / LV end-diastolic volume)
Impact of myocardial perfusion and cardiac cardiac output on perfusion in other organs (kidney, spleen, liver) assed by gadolinium contrast magnetic resonance imaging
Time frame: Baseline and at 5 years follow-up
Myocardial perfusion measured by myocardial blood flow and myocardial perfusion ratio quantified by cardiac MRI.
The association of pericardial- and epicardial fat with myocardial function and MACE after 5 year
Time frame: Baseline and at 5 years follow-up
Myocardial function: LVEF, LV strain (GLS, GCS, GRS), E/e´, myocardial extracellular volume, myocardial perfusion ratio. MACE defined as CVD events (AMI, HF, stable angina, atrial fibrillation, ventricular arytmia), stroke, death
1 secondary outcome
Characterization of the progression of diabetic cardiomyopathy over 5 years, including LV+RV function, the coronary microvascular function, the coronary macrovascular function, fibrosis, aortic stiffness, per and epicardial fat, perfusion of other organs
Time frame: 5 years follow-up
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 22 Jun 2023.
- Individual participant dataSharing planned: Yes. On request and with the proper approvals
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2 and Diabetic Cardiomyopathies, run by Slagelse Hospital at 1 site in Denmark.
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 5 inclusion and 0 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: enrolling by invitation, as of the sponsor's last update on 22 Jun 2023. 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 Denmark. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association of myocardial microvascular function in patients with type 2 diabetes with MACE after 5 years (time frame: 5 years follow-up). The study lists 4 primary outcomes in all. 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 22 Jun 2023.