CMR in T2DM: The NSR Cohort

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

700 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-04-01

Study Completion Date

2030-01-31

Brief Summary

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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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Detailed Description

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Conditions

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Diabetes Mellitus, Type 2 Diabetic Cardiomyopathies Cardiovascular Magnetic Resonance Imaging Coronary Microvascular Dysfunction Myocardium; Fibrosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

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

Intervention Type DIAGNOSTIC_TEST

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

sex and age matched control subjects

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

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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

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

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes