Preclinical Cardiomyopathy and Autonomic Function in Type 1 Diabetes

Preclinical Cardiomyopathy in Type 1 Diabetes: Correlation With Autonomic Dysfunction

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03930004

Enrollment

Registered

2019-04-29

Start date

2018-07-06

Completion date

2019-09-01

Last updated

2019-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

20 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* type 1 diabetes mellitus

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
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%).

Countries

Brazil

Outcome results