Preclinical Cardiomyopathy and Autonomic Function in Type 1 Diabetes

NCT03930004 — Completed, 80 participants, Roberto Léo da Silva

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Preclinical Cardiomyopathy in Type 1 Diabetes: Correlation With Autonomic Dysfunction

Registry	NCT03930004
Status	Completed
Study type	Observational
Enrollment	80 (Actual)
Sponsor	Roberto Léo da Silva (Other)
Conditions	Diabetes Mellitus, Type 1, Diabetic Cardiomyopathies, Autonomic Neuropathy, Diabetic
Dates	start 2018-07-06, primary completion 2019-08-01, completion 2019-09-01, first posted 2019-04-29, last updated 2019-10-08
Locations	1 site in Brazil

-Summary

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.

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+Arms and interventions

Arm	Type	Interventions	Description
Type 1 diabetic patients			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			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.

+Outcome measures

Primary outcomes

Preclinical myocardial dysfunction [At patient inclusion.]: Incidence of patients with alteration in left ventricular myocardial strain (≤ 17% in absolute value).
Left ventricular diastolic dysfunction [At patient inclusion.]: Incidence of patients with signs of diastolic dysfunction: average E/e' ratio (abnormal when > 14)
Left ventricular hypertrophy [At patient inclusion.]: Incidence of patients with LV mass by linear measurements > 95 g/m2 if women and > 115 g/m2 if men.
Left atrial dysfunction [At patient inclusion.]: 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%).

+Eligibility

Sex: All, ages: 20 Years to 55 Years, accepts healthy volunteers

Inclusion Criteria:

* type 1 diabetes mellitus

Exclusion Criteria:

* hypertension
* coronary artery disease
* heart valve disease
* ventricular dysfunction
* radiotherapy or chemotherapy
* alcoholism
* limited acoustic window

+Locations (1)

Facility	City	Country	Status
HU/UFSC	Florianópolis, Santa Catarina	Brazil

+Investigators

Thais R Weber, MD, Study chair, HU/UFSC

My Notes

Public

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