Trials Sponsors Conditions Drugs Pricing

Conditions

Autonomic Neuropathy, Diabetic Diabetes Mellitus, Type 1 Diabetic Cardiomyopathies

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

Age20 Years - 55 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

Sampling MethodNon-Probability Sample

Study Population

Selection of patients from a tertiary hospital.

You may qualify if:

type 1 diabetes mellitus

You may not qualify if:

Sponsors & Collaborators

Roberto Léo da Silva
Otherlead

Study Sites (1)

HU/UFSC

Florianópolis, Santa Catarina, 88036-500, Brazil

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetic CardiomyopathiesDiabetic Neuropathies

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesCardiomyopathiesHeart DiseasesCardiovascular DiseasesDiabetes ComplicationsPeripheral Nervous System Diseases

Study Officials

Thais R Weber, MD
HU/UFSC
STUDY CHAIR

Enrollment

80 participants (actual enrollment reported by the registry).

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

Actual (reported)

Preclinical Cardiomyopathy and Autonomic Function in Type 1 Diabetes

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (4)

Study Arms (2)

Type 1 diabetic patients

Control - Healthy subjects

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (4)

Study Arms (2)

Type 1 diabetic patients

Control - Healthy subjects

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record

Locations