Clinical trial NCT06129448: Tumor Necrosis Factor-alpha Levels and Cardiac Functions in Type 1 Diabetes Mellitus
Official title: Evaluation of Tumor Necrosis Factor-alpha Levels and Cardiac Functions in Pediatric Patients Diagnosed With Type 1 Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 1
Systolic Dysfunction
Diastolic Dysfunction
Keywords: systolic dysfunction
diastolic dysfunction
Diabetes mellitus type 1
pediatric
tissue doppler
Lead sponsor: Sirnak State Hospital
Sponsor class: OTHER_GOV
First posted: 2023-11-13
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with a diagnosis of Type 1 Diabetes Mellitus (T1DM) for more than 1 year will be the first group.

The second group will consist of healthy children without any additional medical conditions, who are similar in terms of age and gender to the children in the first group

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.

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

Primary outcomes:
measure: The percentage of T1DM patients who had decreased systolic left ventricle functions.
timeFrame: 1 month
measure: The percentage of T1DM patients who had decreased diastolic left ventricle functions.
timeFrame: 1 month
measure: The percentage of T1DM patients who had decreased right ventricle functions.
timeFrame: 1 month
measure: Effect of Tumor necrosis factor- α (TNF-α) on cardiac functions
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Sirnak
country: Turkey
facility: Sirnak State Hospital
Study officials:
affiliation: Sirnak State Hospital
name: MERVE MA AYDEMİR
role: STUDY_DIRECTOR
affiliation: Sirnak State Hospital
name: Tahir Çağdaş
role: PRINCIPAL_INVESTIGATOR
affiliation: Sirnak State Hospital
name: Özge Doğan
role: PRINCIPAL_INVESTIGATOR
affiliation: Şırnak Üniversitesi
name: Veysel Tahiroğlu
role: PRINCIPAL_INVESTIGATOR
affiliation: Sirnak State Hospital
name: Cem Mete
role: PRINCIPAL_INVESTIGATOR
affiliation: Siirt University
name: Hasan Karageçili
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.