Preclinical Cardiomyopathy and Autonomic Function in Type 1 Diabetes

NCT03930004 | Completed

• 1 other identifier: HU-UFSC 2018
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• Preclinical myocardial dysfunction

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

  At patient inclusion.

• Left ventricular diastolic dysfunction

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

  At patient inclusion.

• 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.

• 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.

Study Arms (2)

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.

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Selection of patients from a tertiary hospital.

You may qualify if:

• type 1 diabetes mellitus

You may not qualify if:

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

Sponsors & Collaborators

• Roberto Léo da Silva: lead

Study Sites (1)

HU/UFSC

Florianópolis, Santa Catarina, 88036-500, Brazil

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetic Cardiomyopathies; Diabetic Neuropathies

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Diabetes Complications; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Thais R Weber, MD

  HU/UFSC

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Director

Study Record Dates

• First Submitted: February 14, 2019
• First Posted: April 29, 2019
• Study Start: July 6, 2018
• Primary Completion: August 1, 2019
• Study Completion: September 1, 2019
• Last Updated: October 8, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)