Preclinical Cardiomyopathy and Autonomic Function in Type 1 Diabetes

NCT ID: NCT03930004

Last Updated: 2019-10-08

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

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-06

Study Completion Date

2019-09-01

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.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 1 Diabetic Cardiomyopathies Autonomic Neuropathy, Diabetic

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Roberto Léo da Silva

OTHER

Sponsor Role lead

Responsible Party

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Roberto Léo da Silva

Clinical Director

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Thais R Weber, MD

Role: STUDY_CHAIR

HU/UFSC

Locations

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HU/UFSC

Florianópolis, Santa Catarina, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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HU-UFSC 2018

Identifier Type: -

Identifier Source: org_study_id

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