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
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

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