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NCT06356051 Clinical Trial

Cardiovascular Disease Risk in Children With Type 1 Diabetes Mellitus

Type 1 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06356051
Other study ID # Gbuyukyilmaz
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2023
Est. completion date September 1, 2023

Study information
Verified date April 2024
Source Ankara City Hospital Bilkent
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 202
Est. completion date September 1, 2023
Est. primary completion date June 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 8 Years to 18 Years
Eligibility Inclusion Criteria: 1. type T1DM patients 2. body mass index (BMI) between the 5th and 85th percentile according to age and gender 3. having T1DM for at least 2 years 4. ages 8-18 years Exclusion Criteria: 1. having any chronic diseases other than T1DM 2. presence of a congenital and/or acquired heart disease, hypertension etc.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Echocardiography
cardiovascular evaluation

Locations
Country Name City State
Turkey Ankara Bilkent City Hospital Ankara

Sponsors (1)
Lead Sponsor Collaborator
Ankara City Hospital Bilkent

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary Epicardial fat thickness 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. january 2023-june 2023
Secondary carotid intima-media thickness 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. january 2023-june 2023
Secondary arterial stiffness parameters such as pulse wave velocity, augmentation index 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. january 2023-june 2023
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