Preclinical Cardiomyopathy and Autonomic Function in Type 1 Diabetes

Study Overview
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Brief Summary
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Type 1 diabetes mellitus is a chronic autoimmune disease, associated with an increased risk of cardiovascular diseases. The development of cardiomyopathy in type 1 diabetes, independent of hypertension and coronary heart disease, is still controversial. A possible mechanism for diabetic cardiomyopathy is autonomic dysfunction. This study aims to evaluate cardiac function and structure, and to relate them with autonomic dysfunction in type 1 diabetes.

Official Title
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Preclinical Cardiomyopathy in Type 1 Diabetes: Correlation With Autonomic Dysfunction

Conditions
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Diabetes Mellitus, Type 1, Diabetic Cardiomyopathies, Autonomic Neuropathy, Diabetic

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: type 1 diabetes mellitus Exclusion Criteria: hypertension coronary artery disease heart valve disease ventricular dysfunction radiotherapy or chemotherapy alcoholism limited acoustic window

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Type 1 diabetic patients<br>Patients diagnosed with type 1 diabetes mellitus with criteria for cardiovascular autonomic neuropathy, asymptomatic, normotensive, with negative medical history of cardiovascular disease. Transthoracic echocardiography, including: tissue Doppler indices of diastolic filling and speckle tracking for systolic and diastolic strain/strain rate, exclusion of valvular abnormalities, assessment of heart structure and function. | |
| Control - Healthy subjects<br>Fifteen age- and sex-matched healthy control subjects, asymptomatic, normotensive, with negative medical history of cardiovascular disease. Transthoracic echocardiography, including: tissue Doppler indices of diastolic filling and speckle tracking for systolic and diastolic strain/strain rate, exclusion of valvular abnormalities, assessment of heart structure and function. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preclinical myocardial dysfunction | Incidence of patients with alteration in left ventricular myocardial strain (≤ 17% in absolute value). | At patient inclusion. | 
| Left ventricular diastolic dysfunction | Incidence of patients with signs of diastolic dysfunction: average E/e' ratio (abnormal when > 14) | At patient inclusion. | 
| Left ventricular hypertrophy | Incidence of patients with LV mass by linear measurements > 95 g/m2 if women and > 115 g/m2 if men. | At patient inclusion. | 
| Left atrial dysfunction | Incidence of patients with abnormal reservoir strain (normal range: 38%-41%), or abnormal conduit strain (normal range: 21%-25%), or abnormal contractile strain (normal range: 16%-19%). | At patient inclusion. |