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NCT Number: NCT05915260

CMR in T2DM: The NSR 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.

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Cardiomyopathies Cardiovascular Diseases Cardiovascular Magnetic Resonance Imaging Coronary Microvascular Dysfunction Diabetes Complications Diabetes Mellitus Diabetic Cardiomyopathies Endocrine System Diseases Fibrosis Glucose Metabolism Disorders Heart Diseases Metabolic Diseases Myocardium; Fibrosis Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Slagelse Hospital, department of cardiology and endocrinology, medicine 2

Slagelse, 4200, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

All subjects will undergo cardiac magnetic resonance imaging with gadolinium contrast and with adenosine myocardial perfusion

Diagnostic Test

This is a observational follow up study accordingly all subjects will undergo the same examinations

Other names: Echocardiography, medical interview, general medical examination, BP, HR e.g., Examination for non cardiac complications to diabetes

Primary outcomes

  1. 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

  2. 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)

  3. 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.

  4. 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

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Slagelse Hospital

Other

Collaborators

  • Herlev Hospital

Registry information

Official study title

Cardiac Magnetic Resonance Imaging in Type 2 Diabetes Mellitus: The Næstved/Slagelse/Ringsted Cohort

Important dates

Study start
2023
Primary completion
2026
Study completion
2030
First posted
Jun 22, 2023
Registry last updated
Jun 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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