CMR in T2DM: The NSR Cohort

• Conditions: Diabetes Mellitus, Type 2; Coronary Microvascular Dysfunction; Myocardium; Fibrosis; Diabetic Cardiomyopathies; Cardiovascular Magnetic Resonance Imaging
• Interventions: Diagnostic Test: All subjects will undergo cardiac magnetic resonance imaging with gadolinium contrast and with adenosine myocardial perfusion

• Registration Number: NCT05915260
• Lead Sponsor: Slagelse Hospital

Brief 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.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-01
• Study First Submitted: 2023-05-25
• Status Verified: 2023-06
• Study First Submitted QC: 2023-06-13
• Last Update Submitted: 2023-06-13
• Study First Posted: 2023-06-22
• Last Update Posted: 2023-06-22
• Primary Completion: 2026-12-31
• Study Completion: 2030-01-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 700

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
sex and age matched control subjects	All subjects will undergo cardiac magnetic resonance imaging with gadolinium contrast and with adenosine myocardial perfusion	-
Patients with type 2 diabetes	All subjects will undergo cardiac magnetic resonance imaging with gadolinium contrast and with adenosine myocardial perfusion	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

Primary Outcome Measures

Name	Time	Method
Clinical factors associated with worsening of diabetic cardiomyopathy after 5 years	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)
The association of pericardial- and epicardial fat with myocardial function and MACE after 5 year	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
Association of myocardial microvascular function in patients with type 2 diabetes with MACE after 5 years	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
Impact of myocardial perfusion and cardiac cardiac output on perfusion in other organs (kidney, spleen, liver) assed by gadolinium contrast magnetic resonance imaging	Baseline and at 5 years follow-up	Myocardial perfusion measured by myocardial blood flow and myocardial perfusion ratio quantified by cardiac MRI.

Secondary Outcome Measures

Name	Time	Method
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	5 years follow-up	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.

Trial Locations

Locations (1)

Slagelse Hospital, department of cardiology and endocrinology, medicine 2; 🇩🇰 Slagelse, Denmark