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Clinical Trials/NCT03930004
NCT03930004
Completed
Not Applicable

Preclinical Cardiomyopathy in Type 1 Diabetes: Correlation With Autonomic Dysfunction

Roberto Léo da Silva1 site in 1 country80 target enrollmentJuly 6, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetes Mellitus, Type 1
Sponsor
Roberto Léo da Silva
Enrollment
80
Locations
1
Primary Endpoint
Left ventricular hypertrophy
Status
Completed
Last Updated
6 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
July 6, 2018
End Date
September 1, 2019
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Roberto Léo da Silva
Responsible Party
Sponsor Investigator
Principal Investigator

Roberto Léo da Silva

Clinical Director

Instituto de Cardiologia de Santa Catarina

Eligibility Criteria

Inclusion Criteria

  • type 1 diabetes mellitus

Exclusion Criteria

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

Outcomes

Primary Outcomes

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.

Left ventricular diastolic dysfunction

Time Frame: At patient inclusion.

Incidence of patients with signs of diastolic dysfunction: average E/e' ratio (abnormal when \> 14)

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%).

Preclinical myocardial dysfunction

Time Frame: At patient inclusion.

Incidence of patients with alteration in left ventricular myocardial strain (≤ 17% in absolute value).

Study Sites (1)

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