Cardiovascular Disease Risk in Children With Type 1 Diabetes Mellitus

NCT06356051 | Completed

• 1 other identifier: Gbuyukyilmaz
• Study Type: observational
• Target: 202
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• carotid intima-media thickness

  january 2023-june 2023

• arterial stiffness parameters such as pulse wave velocity, augmentation index

  january 2023-june 2023

Study Arms (2)

Type1 diabetes mellitus

Device: Echocardiography

Healthy children

Device: Echocardiography

Interventions

Echocardiography DEVICE

cardiovascular evaluation

Also known as: oscillometric Mobil-O-Graph device

Healthy children; Type1 diabetes mellitus

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

type 1 diabetes mellitus and age and gender mathced healthy children

You may qualify if:

• 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

You may not qualify if:

• having any chronic diseases other than T1DM
• presence of a congenital and/or acquired heart disease, hypertension etc.

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2024
• First Posted: April 10, 2024
• Study Start: January 1, 2023
• Primary Completion: June 1, 2023
• Study Completion: September 1, 2023
• Last Updated: April 10, 2024

Record last verified: 2024-04

Locations

TU (1)