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Cardiovascular Disease Risk in Children With Type 1 Diabetes Mellitus

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06356051
Enrollment
202
Registered
2024-04-10
Start date
2023-01-01
Completion date
2023-09-01
Last updated
2024-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes

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.

Interventions

DEVICEEchocardiography

cardiovascular evaluation

Sponsors

Ankara City Hospital Bilkent
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
8 Years to 18 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Epicardial fat thicknessjanuary 2023-june 2023Epicardial 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

MeasureTime frameDescription
carotid intima-media thicknessjanuary 2023-june 2023carotid 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.
arterial stiffness parameters such as pulse wave velocity, augmentation indexjanuary 2023-june 2023cuff-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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026