Evaluation of Tumor Necrosis Factor-alpha Levels and Cardiac Functions in Pediatric Patients Diagnosed With Type 1 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The percentage of T1DM patients who had decreased diastolic left ventricle functions.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •Having an additional cardiac anomaly
- •Having an additional chronic medical condition
结局指标
主要结局
The percentage of T1DM patients who had decreased diastolic left ventricle functions.
时间窗: 1 month
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.
The percentage of T1DM patients who had decreased systolic left ventricle functions.
时间窗: 1 month
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.
The percentage of T1DM patients who had decreased right ventricle functions.
时间窗: 1 month
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.
Effect of Tumor necrosis factor- α (TNF-α) on cardiac functions
时间窗: 1 month
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.
次要结局
未报告次要终点
研究者
Merve Maze AYDEMIR
medical doctorat at pediatric cardiology unit
Sirnak State Hospital