Tumor Necrosis Factor-alpha Levels and Cardiac Functions in Type 1 Diabetes Mellitus

Sirnak State Hospital

Status: Completed

Conditions: Diabetes Mellitus, Type 1; Diastolic Dysfunction; Systolic Dysfunction

Treatments: Diagnostic Test: transthoracic echocardiography

Study type: Observational

Funder types: Other

Identifiers

NCT06129448

Sirnakstatehospitalmaydemir001

Details and patient eligibility

About

The goal of this clinical trial is to learn about the effect of type 1 diabetes mellitus on cardiac functions and evaluate the correlation of the dysfunction with the tumor necrosis factor-α (TNF-α) an inflammation-related factor. The study population will be the patients with the diagnosis of type 1 diabetes mellitus and the healthy children es the control group. The main question[s] it aims to answer are:

• Is diabetes affecting the systolic and diastolic cardiac functions
• Is diabetes affecting the left and the right ventricles equally?
• Does diabetes status, as assessed by HbA1c, have an impact on the occurrence of cardiac dysfunction?
• Is TNF-α can be a marker for early diagnosis of cardiac dysfunction? Diabetic patients will be examined by both a pediatric endocrinologist and a pediatric cardiologist. Transthoracic echocardiography will be performed and TNF-α will be evaluated for both the diabetic patients and the healthy children.

Full description

Type 1 Diabetes Mellitus (T1DM) patients are at risk of developing cardiac dysfunction, a serious complication. Conventional echocardiography and tissue Doppler echocardiography are the most commonly used methods to evaluate cardiac functions. This study aims to prospectively assess the cardiac functions of pediatric patients diagnosed with T1DM. After routine pediatric endocrinology assessments, including anthropometric measurements, monitoring of blood glucose charts, and inquiring about complications related to diabetes, patients will be referred for pediatric cardiology evaluation. Standard pediatric cardiac examination, electrocardiographic evaluation, and echocardiography, including conventional transthoracic echocardiography and tissue Doppler echocardiography, will be performed.

Patients with a T1DM diagnosis typically provide blood samples for standard tests (HgA1c, blood glucose, routine biochemistry, etc.) following each pediatric endocrinology visit. In this study, an additional blood sample will be taken during blood collection to measure tumor necrosis factor-alpha (TNF-α) levels. Previous studies have shown elevated TNF-α levels in T1DM patients. This study aims to investigate its potential impact on cardiac function. Similarly, an age- and gender-matched control group of healthy children without T1DM will be established. This control group will also undergo echocardiographic evaluation, and TNF-α levels in their blood will be measured. Subsequently, statistical analysis will be conducted.

Through these assessments, this study aims to determine whether there is a deterioration in systolic and diastolic heart functions in the pediatric T1DM patient group compared to the control group and to evaluate the effect of TNF-α levels on these results.

Enrollment: 60 patients

Sex: All

Ages: 1 to 18 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

-Patients with a diagnosis of Type 1 Diabetes Mellitus (T1DM) who have been under follow-up for at least 1 year (for the patient group)

Exclusion criteria

• Having an additional cardiac anomaly
• Having an additional chronic medical condition

Trial design

60 participants in 2 patient groups

Diabetes Mellitus

Description:

We will include in this group patients with a diagnosis of T1DM, determined according to the World Health Organization criteria, who need insulin treatment and whose diabetes duration is more than 1 year. Patients will not have additional chronic diseases and will not have any other medical treatments other than insulin.

Treatment:

Diagnostic Test: transthoracic echocardiography

Healthy Children

Description:

Patients will not have additional chronic diseases or other medical treatments. They will often be selected on a voluntary basis from patients who apply to pediatric cardiology with symptoms such as murmur or chest pain.

Treatment:

Diagnostic Test: transthoracic echocardiography