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Preclinical Cardiomyopathy and Autonomic Function in Type 1 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03930004
Recruitment Status : Completed
First Posted : April 29, 2019
Last Update Posted : October 8, 2019
Sponsor:
Information provided by (Responsible Party):
Roberto Léo da Silva, Instituto de Cardiologia de Santa Catarina

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

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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

Resource links provided by the National Library of Medicine


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.




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%).



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03930004


Locations
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Brazil
HU/UFSC
Florianopolis, SC, Brazil, 88036-500
Sponsors and Collaborators
Roberto Léo da Silva
Investigators
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Study Chair: Thais R Weber, MD HU/UFSC
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Responsible Party: Roberto Léo da Silva, Clinical Director, Instituto de Cardiologia de Santa Catarina
ClinicalTrials.gov Identifier: NCT03930004    
Other Study ID Numbers: HU-UFSC 2018
First Posted: April 29, 2019    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetic Neuropathies
Cardiomyopathies
Diabetic Cardiomyopathies
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Heart Diseases
Cardiovascular Diseases
Diabetes Complications
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases