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

NCT06129448 | Completed

• 1 other identifier: Sirnakstatehospitalmaydemir001
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 1; Systolic Dysfunction; Diastolic Dysfunction

Keywords

systolic dysfunction; diastolic dysfunction; Diabetes mellitus type 1; pediatric; tissue doppler

Outcome Measures

Primary Outcomes (4)

• The percentage of T1DM patients who had decreased systolic left ventricle functions.

  We will include Type 1 DM patients diagnosed for over a year. After routine pediatric endocrinology assessments, they'll visit the pediatric cardiology clinic. By echocardiography, ejection fraction (EF) and fractional shortening (FS) will be measured in percentages. For these calculations, Left ventricular end-diastolic dimension, Interventricular septum, and LV posterior wall thickness in systole and diastole will be measured in mm. The expected normal value for EF is \>%55 and FS \> %30.

  1 month

• The percentage of T1DM patients who had decreased diastolic left ventricle functions.

  To assess diastolic dysfunction by echocardiography, the mitral diastolic flow tracings will be imaged in pulsed Doppler with sample volume sited at the tips of the mitral leaflets. Peak velocities of early (E) and late (A) filling (m/s) will be derived from atrioventricular valve inflow velocity profiles. The early to late peak velocities (E/A) ratio will be calculated. In addition, by tissue Doppler imaging echocardiography, myocardial wall motion velocity will be recorded by activating the pulsed-wave (PW) tissue Doppler function on the same machine. LV septal and lateral mitral annulus measures: early (Em) and late (Am) (m/s) diastolic myocardial velocities, isovolumic contraction time , isovolumic relaxation time and ejection time (ms) will be measured. The myocardial performance index will be calculated as (IVCT + IVRT)/ET.

  1 month

• The percentage of T1DM patients who had decreased right ventricle functions.

  The tricuspid diastolic flow tracings will be imaged in pulsed Doppler to assess diastolic dysfunction by echocardiography. Peak velocities of early (E) and late (A) filling (m/s) will be derived from atrioventricular valve inflow velocity profiles. The early to late peak velocities (E/A) ratio will be calculated. In addition, by tissue. For lateral tricuspid annulus, early (Em) and late (Am) (m/s) diastolic myocardial velocities, isovolumic contraction time, isovolumic relaxation time, and ejection time (ms) will be measured by Doppler imaging echocardiography. The myocardial performance index will be calculated as (IVCT + IVRT)/ET. Tricuspid annular plane systolic excursion (TAPSE) (mm) will be assessed for systolic function.

  1 month

• Effect of Tumor necrosis factor- α (TNF-α) on cardiac functions

  This study will include T1DM patients diagnosed for over a year who have undergone routine pediatric endocrinology evaluations. We'll collect extra blood samples to measure TNF-α levels (pg/mL). We will evaluate whether blood TNF-α levels are higher in patients who develop systolic and/or diastolic dysfunction compared to patients who do not develop dysfunction.

  1 month

Study Arms (2)

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.

Diagnostic Test: transthoracic echocardiography

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.

Diagnostic Test: transthoracic echocardiography

Interventions

transthoracic echocardiography 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.

Diabetes Mellitus; Healthy Children

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Sirnak State Hospital: lead

Study Sites (1)

Sirnak State Hospital

Şırnak, 73000, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 29205484 BACKGROUND

• 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.

  PMID: 28400931 BACKGROUND

• 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.

  PMID: 37189738 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be taken for the analyses of TNF-a.

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 Officials

• MERVE MA AYDEMİR

  Sirnak State Hospital

  STUDY DIRECTOR

• Tahir Çağdaş

  Sirnak State Hospital

  PRINCIPAL INVESTIGATOR

• Özge Doğan

  Sirnak State Hospital

  PRINCIPAL INVESTIGATOR

• Veysel Tahiroğlu

  Şırnak Üniversitesi

  PRINCIPAL INVESTIGATOR

• Cem Mete

  Sirnak State Hospital

  PRINCIPAL INVESTIGATOR

• Hasan Karageçili

  Siirt University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: medical doctorat at pediatric cardiology unit

Study Record Dates

• First Submitted: November 3, 2023
• First Posted: November 13, 2023
• Study Start: December 1, 2023
• Primary Completion: January 30, 2024
• Study Completion: February 1, 2024
• Last Updated: April 25, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)