Cardiovascular Disease Risk in Children With Type 1 Diabetes Mellitus

Completed

• Conditions: Type 1 Diabetes
• Interventions: Device: Echocardiography

• Registration Number: NCT06356051
• Lead Sponsor: Ankara City Hospital Bilkent

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-01
• Primary Completion: 2023-06-01
• Study Completion: 2023-09-01
• Study First Submitted: 2024-03-25
• Status Verified: 2024-04
• Study First Submitted QC: 2024-04-02
• Last Update Submitted: 2024-04-02
• Study First Posted: 2024-04-10
• Last Update Posted: 2024-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 202

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Type1 diabetes mellitus	Echocardiography	-
Healthy children	Echocardiography	-

Primary Outcome Measures

Name	Time	Method
Epicardial fat thickness	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 Outcome Measures

Name	Time	Method
arterial stiffness parameters such as pulse wave velocity, augmentation index	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.
carotid intima-media thickness	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.

Trial Locations

Locations (1)

Ankara Bilkent City Hospital; 🇹🇷 Ankara, Turkey