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

NCT ID: NCT06129448

Last Updated: 2024-04-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-12-01
• Study Completion Date: 2024-02-01

Brief Summary

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.

Detailed 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.

Conditions

Diabetes Mellitus, Type 1; Systolic Dysfunction; Diastolic Dysfunction

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Diabetes Mellitus

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.

transthoracic echocardiography

Intervention Type: DIAGNOSTIC_TEST

All echocardiographic studies will be performed by one physician (Merve Maze AYDEMIR) using a commercially available echocardiographic system (P4-2 probe, DC-60, Mindray, Shenzhen, China) in the back-to-top or left lateral decubitus position. All images will be digitally stored from three cardiac cycles as standard apical four-chamber and parasternal short-axis views.

Healthy Children

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.

transthoracic echocardiography

Intervention Type: DIAGNOSTIC_TEST

All echocardiographic studies will be performed by one physician (Merve Maze AYDEMIR) using a commercially available echocardiographic system (P4-2 probe, DC-60, Mindray, Shenzhen, China) in the back-to-top or left lateral decubitus position. All images will be digitally stored from three cardiac cycles as standard apical four-chamber and parasternal short-axis views.

Interventions

transthoracic echocardiography

All echocardiographic studies will be performed by one physician (Merve Maze AYDEMIR) using a commercially available echocardiographic system (P4-2 probe, DC-60, Mindray, Shenzhen, China) in the back-to-top or left lateral decubitus position. All images will be digitally stored from three cardiac cycles as standard apical four-chamber and parasternal short-axis views.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sirnak State Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Merve Maze AYDEMIR

medical doctorat at pediatric cardiology unit

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

MERVE MA AYDEMİR

Role: STUDY_DIRECTOR

Sirnak State Hospital

Tahir Çağdaş

Role: PRINCIPAL_INVESTIGATOR

Sirnak State Hospital

Özge Doğan

Role: PRINCIPAL_INVESTIGATOR

Sirnak State Hospital

Veysel Tahiroğlu

Role: PRINCIPAL_INVESTIGATOR

Şırnak Üniversitesi

Cem Mete

Role: PRINCIPAL_INVESTIGATOR

Sirnak State Hospital

Hasan Karageçili

Role: PRINCIPAL_INVESTIGATOR

Siirt University

Locations

Sirnak State Hospital

Şırnak, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Yoldas T, Orun UA, Sagsak E, Aycan Z, Kaya O, Ozgur S, Karademir S. Subclinical left ventricular systolic and diastolic dysfunction in type 1 diabetic children and adolescents with good metabolic control. Echocardiography. 2018 Feb;35(2):227-233. doi: 10.1111/echo.13764. Epub 2017 Dec 3.

Reference Type: BACKGROUND

PMID: 29205484 (View on PubMed)

M Abd-El Aziz F, Abdelghaffar S, M Hussien E, M Fattouh A. Evaluation of Cardiac Functions in Children and Adolescents with Type 1 Diabetes. J Cardiovasc Ultrasound. 2017 Mar;25(1):12-19. doi: 10.4250/jcu.2017.25.1.12. Epub 2017 Mar 27.

Reference Type: BACKGROUND

PMID: 28400931 (View on PubMed)

Dos Santos Haber JF, Barbalho SM, Sgarbi JA, de Argollo Haber RS, de Labio RW, Laurindo LF, Chagas EFB, Payao SLM. The Relationship between Type 1 Diabetes Mellitus, TNF-alpha, and IL-10 Gene Expression. Biomedicines. 2023 Apr 7;11(4):1120. doi: 10.3390/biomedicines11041120.

Reference Type: BACKGROUND

PMID: 37189738 (View on PubMed)

Other Identifiers

Sirnakstatehospitalmaydemir001

Identifier Type: -

Identifier Source: org_study_id