Preclinical Cardiomyopathy and Autonomic Function in Type 1 Diabetes

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

Preclinical Cardiomyopathy in Type 1 Diabetes: Correlation With Autonomic Dysfunction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03930004
• Other study ID #: HU-UFSC 2018
• Status: Completed
• Start date: July 6, 2018
• Est. completion date: September 1, 2019

Study information

• Verified date: October 2019
• Source: Instituto de Cardiologia de Santa Catarina
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 1, 2019
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 55 Years

Eligibility

Inclusion Criteria:

• type 1 diabetes mellitus

Exclusion Criteria:

• hypertension

• coronary artery disease

• heart valve disease

• ventricular dysfunction

• radiotherapy or chemotherapy

• alcoholism

• limited acoustic window

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Brazil	HU/UFSC	Florianopolis	SC

Sponsors (1)

Lead Sponsor	Collaborator
Roberto Léo da Silva

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preclinical myocardial dysfunction	Incidence of patients with alteration in left ventricular myocardial strain (= 17% in absolute value).	At patient inclusion.
Primary	Left ventricular diastolic dysfunction	Incidence of patients with signs of diastolic dysfunction: average E/e' ratio (abnormal when > 14)	At patient inclusion.
Primary	Left ventricular hypertrophy	Incidence of patients with LV mass by linear measurements > 95 g/m2 if women and > 115 g/m2 if men.	At patient inclusion.
Primary	Left atrial dysfunction	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.