Preclinical Cardiomyopathy and Autonomic Function in Type 1 Diabetes

Completed

• Conditions: Diabetic Cardiomyopathies; Diabetes Mellitus, Type 1; Autonomic Neuropathy, Diabetic

• Registration Number: NCT03930004
• Lead Sponsor: Roberto Léo da Silva

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-06
• Study First Submitted: 2019-02-14
• Study First Submitted QC: 2019-04-25
• Study First Posted: 2019-04-29
• Primary Completion: 2019-08-01
• Study Completion: 2019-09-01
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-06
• Last Update Posted: 2019-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

HU/UFSC; 🇧🇷 Florianopolis, SC, Brazil