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Currently, you can access the following clinical trials being conducted worldwide:

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/16/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/16/2021.

Preclinical Cardiomyopathy and Autonomic Function in Type 1 Diabetes

Clinicaltrials.gov identifier NCT03930004

Recruitment Status Completed

First Posted April 29, 2019

Last update posted October 8, 2019

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
  • Intervention/Treatment:
  • Phase: N/A
Detailed Description

N/A

Study Design
  • 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 2018
  • Actual Primary Completion Date: August 2019
  • Actual Study Completion Date: September 2019
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
  • Ages Eligible for Study: 20 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
Contacts
Locations

Brazil, SC
HU/UFSC
Florianopolis

Sponsors and Collaborators

Roberto Léo da Silva

Investigators

Study Chair: Thais R Weber, MD HU/UFSC

More Information
  • Responsible Party: Roberto Léo da Silva
  • ClinicalTrials.gov Identifier: NCT03930004 History of Changes
  • 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
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Diabetic Neuropathies
    Cardiomyopathies
    Diabetic Cardiomyopathies
    Diabetes Mellitus
    Diabetes Mellitus, Type 1