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OpenTrials
Completed

NCT Number: NCT06356051

Cardiovascular Disease Risk in Children With Type 1 Diabetes Mellitus

Epicardial fat thickness, carotid intima-media thickness, and augmentation index from arterial stiffness indicators are increased in children with T1DM compared to the healthy control group. These results support the idea that children with T1DM present significant changes in important subclinical indicators for the development of cardiovascular disease.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ankara Bilkent City Hospital

Ankara, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • type T1DM patients
  • body mass index (BMI) between the 5th and 85th percentile according to age and gender
  • having T1DM for at least 2 years
  • ages 8-18 years

Exclusion criteria

  • having any chronic diseases other than T1DM
  • presence of a congenital and/or acquired heart disease, hypertension etc.

Treatment and study plan

Echocardiography

Device

cardiovascular evaluation

Other names: oscillometric Mobil-O-Graph device

Primary outcomes

  1. Epicardial fat thickness

    Time frame: january 2023-june 2023

    Epicardial fat thickness was measured with Echocardiography as milimeter. Epicardial fat was identified as the echo-free space between the outer wall of the myocardium and the visceral layer of pericardium. The values of children with type 1 DM were compared with healthy children. Values are given as mean and standard deviation.

Secondary outcomes

  1. carotid intima-media thickness

    Time frame: january 2023-june 2023

    carotid intima-media thickness were measured by echocardiography machine as milimeter. cIMT is defined as the distance between the first echogenic line (lumen-intima interface) and the second echogenic line (media-adventitia interface) of the far wall. The values of children with type 1 DM were compared with healthy children. Values are given as mean and standard deviation.

  2. arterial stiffness parameters such as pulse wave velocity, augmentation index

    Time frame: january 2023-june 2023

    cuff-based validated oscillometric Mobil-O-Graph device (I.E.M., GmbH, Aachen, Germany) was used to these parameters. Data from the Mobil-O Graph device was exported and analyzed using Hypertension Management Software Client-Server version 5.2.3. The values of children with type 1 DM were compared with healthy children. Values are given as mean and standard deviation.

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

Evaluation of Cardiovascular Disease Risk in Children With Type 1 Diabetes Mellitus by Oscillometric Method and Echocardiography

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 10, 2024
Registry last updated
Apr 10, 2024

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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