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

Ankara City Hospital Bilkent1 site in 1 country202 target enrollmentJanuary 1, 2023

ConditionsType 1 Diabetes

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Type 1 Diabetes
Sponsor: Ankara City Hospital Bilkent
Enrollment: 202
Locations: 1
Primary Endpoint: Epicardial fat thickness
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

January 1, 2023

End Date

September 1, 2023

Last Updated

2 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Ankara City Hospital Bilkent

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

arterial stiffness parameters such as pulse wave velocity, augmentation index(january 2023-june 2023)
carotid intima-media thickness(january 2023-june 2023)