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Completed

NCT Number: NCT03930004

Preclinical Cardiomyopathy and Autonomic Function in Type 1 Diabetes

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.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Autonomic Neuropathy, Diabetic Cardiomyopathies Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Cardiomyopathies Diabetic Neuropathies Endocrine System Diseases Glucose Metabolism Disorders Heart Diseases Immune System Diseases Metabolic Diseases Nervous System Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Peripheral Nervous System Diseases

Age range

20 year–55 year

Sex eligibility

All sexes

Study type

Observational

Primary location

HU/UFSC

Florianópolis, Santa Catarina, 88036-500, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • type 1 diabetes mellitus

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  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%).

Sponsors and collaborators

Lead sponsor

Roberto Léo da Silva

Other

Registry information

Official study title

Preclinical Cardiomyopathy in Type 1 Diabetes: Correlation With Autonomic Dysfunction

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 29, 2019
Registry last updated
Oct 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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