Preclinical Cardiomyopathy and Autonomic Function in Type 1 Diabetes

October 6, 2019 updated by: Roberto Léo da Silva

Preclinical Cardiomyopathy in Type 1 Diabetes: Correlation With Autonomic Dysfunction

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SC
      • Florianopolis, SC, Brazil, 88036-500
        • HU/UFSC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Selection of patients from a tertiary hospital.

Description

Inclusion Criteria:

  • type 1 diabetes mellitus

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preclinical myocardial dysfunction
Time Frame: At patient inclusion.
Incidence of patients with alteration in left ventricular myocardial strain (≤ 17% in absolute value).
At patient inclusion.
Left ventricular diastolic dysfunction
Time Frame: At patient inclusion.
Incidence of patients with signs of diastolic dysfunction: average E/e' ratio (abnormal when > 14)
At patient inclusion.
Left ventricular hypertrophy
Time Frame: At patient inclusion.
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
Time Frame: 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%).
At patient inclusion.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Roberto Léo da Silva

Investigators

  • Study Chair: Thais R Weber, MD, HU/UFSC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 6, 2018

Primary Completion (Actual)

August 1, 2019

Study Completion (Actual)

September 1, 2019

Study Registration Dates

First Submitted

February 14, 2019

First Submitted That Met QC Criteria

April 25, 2019

First Posted (Actual)

April 29, 2019

Study Record Updates

Last Update Posted (Actual)

October 8, 2019

Last Update Submitted That Met QC Criteria

October 6, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HU-UFSC 2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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