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出境医 / 临床实验 / Preclinical Cardiomyopathy and Autonomic Function in Type 1 Diabetes

Preclinical Cardiomyopathy and Autonomic Function in Type 1 Diabetes

Study Description
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.

Condition or disease
Diabetes Mellitus, Type 1 Diabetic Cardiomyopathies Autonomic Neuropathy, Diabetic

Study Design
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Study Type : Observational
Actual Enrollment : 80 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Preclinical Cardiomyopathy in Type 1 Diabetes: Correlation With Autonomic Dysfunction
Actual Study Start Date : July 6, 2018
Actual Primary Completion Date : August 1, 2019
Actual Study Completion Date : September 1, 2019
Arms and Interventions
Group/Cohort
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.
Outcome Measures
Primary Outcome Measures :
  1. Preclinical myocardial dysfunction [ Time Frame: At patient inclusion. ]
    Incidence of patients with alteration in left ventricular myocardial strain (≤ 17% in absolute value).

  2. Left ventricular diastolic dysfunction [ Time Frame: At patient inclusion. ]
    Incidence of patients with signs of diastolic dysfunction: average E/e' ratio (abnormal when > 14)

  3. Left ventricular hypertrophy [ Time Frame: At patient inclusion. ]
    Incidence of patients with LV mass by linear measurements > 95 g/m2 if women and > 115 g/m2 if men.

  4. Left atrial dysfunction [ Time Frame: 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%).


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Selection of patients from a tertiary hospital.
Criteria

Inclusion Criteria:

  • type 1 diabetes mellitus

Exclusion Criteria:

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

Locations
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Brazil
HU/UFSC
Florianopolis, SC, Brazil, 88036-500
Sponsors and Collaborators
Roberto Léo da Silva
Investigators
Layout table for investigator information
Study Chair: Thais R Weber, MD HU/UFSC
Tracking Information
First Submitted Date February 14, 2019
First Posted Date April 29, 2019
Last Update Posted Date October 8, 2019
Actual Study Start Date July 6, 2018
Actual Primary Completion Date August 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 28, 2019)
  • Preclinical myocardial dysfunction [ Time Frame: At patient inclusion. ]
    Incidence of patients with alteration in left ventricular myocardial strain (≤ 17% in absolute value).
  • Left ventricular diastolic dysfunction [ Time Frame: At patient inclusion. ]
    Incidence of patients with signs of diastolic dysfunction: average E/e' ratio (abnormal when > 14)
  • Left ventricular hypertrophy [ Time Frame: 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 [ Time Frame: 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%).
Original Primary Outcome Measures
 (submitted: April 25, 2019)
  • Preclinical myocardial dysfunction [ Time Frame: At patient inclusion. ]
    Alteration in left ventricular myocardial strain (≤ 17% in absolute value).
  • Left ventricular diastolic dysfunction [ Time Frame: At patient inclusion. ]
    Signs of diastolic dysfunction: average E/e' ratio (abnormal when > 14)
  • Left ventricular hypertrophy [ Time Frame: At patient inclusion. ]
    Defined as LV mass by linear measurements > 95 g/m2 in women and > 115 g/m2 in men.
  • Left atrial function [ Time Frame: At patient inclusion. ]
    Normal reservoir strain of 39% (range: 38%-41%), for conduit strain of 23% (range: 21%-25%), and for contractile strain of 17% (range: 16%-19%).
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Preclinical Cardiomyopathy and Autonomic Function in Type 1 Diabetes
Official Title Preclinical Cardiomyopathy in Type 1 Diabetes: Correlation With Autonomic Dysfunction
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 Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Selection of patients from a tertiary hospital.
Condition
  • Diabetes Mellitus, Type 1
  • Diabetic Cardiomyopathies
  • Autonomic Neuropathy, Diabetic
Intervention Not Provided
Study Groups/Cohorts
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 6, 2019) 		80
Original Estimated Enrollment
 (submitted: April 25, 2019) 		50
Actual Study Completion Date September 1, 2019
Actual Primary Completion Date August 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • type 1 diabetes mellitus

Exclusion Criteria:

  • hypertension
  • coronary artery disease
  • heart valve disease
  • ventricular dysfunction
  • radiotherapy or chemotherapy
  • alcoholism
  • limited acoustic window
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years to 55 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Brazil
Removed Location Countries  
 
Administrative Information
NCT Number NCT03930004
Other Study ID Numbers HU-UFSC 2018
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Roberto Léo da Silva, Instituto de Cardiologia de Santa Catarina
Study Sponsor Roberto Léo da Silva
Collaborators Not Provided
Investigators
Study Chair: Thais R Weber, MD HU/UFSC
PRS Account Instituto de Cardiologia de Santa Catarina
Verification Date October 2019

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