Flow-mediated Arterial Dilatation, Hypertension, Endothelin-1 (ET-1) and Soluble Intercellular Adhesion Molecule (sICAM-1) in Obese Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Hip circumference (HC)
研究概览
简要总结
Obesity in adolescents is associated with the development of cardiovascular disease and type 2 diabetes mellitus. In order to detect early development of cardiovascular disease, early detection of the endothelium of obese adolescents is needed. Endothelium dysfunction is an early stage of developing atherosclerosis, which can be a predictor of cardiovascular disease development in the future. Flow mediated dilatation (FMD) is a non-invasive method that can measure endothelium function and predict the risk of cardiovascular disease, which is not only able to measure artery diameter, but also provides function index of nitric oxide (NO) in the endothelium. FMD is negatively related to BMI. Meanwhile, Endothelin-1 (ET-1) is thought to play a role in the pathogenesis of insulin resistance, because when its levels increase, ET-1 can cause a condition of hyperinsulinemia. ET-1 was found to be high in patients with cardiovascular disorders, as well as in obese and diabetic subjects. Alternative methods for assessing endothelial function by measurement of biomarkers of activation and endothelial dysfunction such as soluble intercellular adhesion molecule-1 (sICAM-1). Levels of sICAM-1 have been found to be related positively to age, systolic and diastolic blood pressure, hypercholesterolemia, hypertriglyceridemia and inversely to estrogen. Furthermore, associations have been found between sICAM-1 and cardiovascular mortality in both healthy individuals and populations at high risk.
The aim of the study was to evaluate FMD, concentrations of ET-1 and sICAM-1 in adolescents with a presence of obesity and hypertension and to compare these with controls (obesity and non hypertension), as well as to analyze the correlations between FMD, ET-1, sICAM-1 and blood pressure values.
详细描述
This study is cross sectional study with observational analytic that evaluates FMD, ET-1 dan sICAM-1 in obese adolescents with hypertension compared to obese adolescents without hypertension and normal adolescents. The subjects are 70 adolescents (obese and normal) aged 13-18 years, healthy, not undergoing any medication, not smoking and not drinking alcohol, which are further divided into 3 groups: obesity with hypertension, obesity without hypertension and normal. Examination includes blood pressure examination, brachial ultrasound and blood sampling to measure levels of profile lipid, blood glucose, ET-1, and sICAM-1. Blood sample of subjects were taken by laboratory employee of the general hospital in Surabaja, Indonesia.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 13 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Study in Junior or Senior High School in Surabaja city
排除标准
- •Smoking or consuming alcohol
- •Suffering from infections, inflammation, autoimmune diseases, cancer, chronic diseases, and endocrine disorders
- •consuming steroids or hormone therapy
结局指标
主要结局
Hip circumference (HC)
时间窗: 5 months
Hip circumference will be measured using Seca 201 measuring tape (in cm), by asking the subjects to keep the feet together, then wrapping the measuring tape around the widest part of the hips, at the point of the greatest gluteal protuberance. The subjects were measured using light cloth without food wear and other accessories such as belts, hats, hair accessories, etc. The data will be presented as mean +/- SD
Waist circumference (WC)
时间窗: 5 months
Waist circumference will be measured using Seca 201 measuring tape (in cm), Waist circumference was measured by wrapping the measuring tape around the subject's stomach, at the midpoint between the lowest rib and the endpoint of the iliac crest upon expiration, in line with the navel. The subjects were measured using light cloth without food wear and other accessories such as belts, hats, hair accessories, etc. The data will be presented as mean +/- standard deviation (SD)
Flow-mediated Arterial Dilatation diameter
时间窗: 5 months
FMD was calculated as the maximum percentage increase in diameter of the brachial artery after ischemia of the forearm. The measurements were performed in supine position at the elbow of the right arm. The cuff was placed on the forearm, distally to the measurement site. The duration of ischemia of the forearm was 5 min. All lumen diameter measurements were done at end diastole by the use of the R-wave of the electrocardiogram. The ultrasound images were made by one technician with a 7.5 megahertz (MHz) linear array transducer of an Ultramark duplex scanner. All images were stored on flash-disk for off-line analysis. Measurement of the endothelium-independent vasodilatation using nitroglycerine, was not performed.
Body height
时间窗: 5 months
Body height will be measured using Seca 213 stadiometer. The subjects were asked to step at the stadiometer base in an upright state, with the heel, the buttock, and the shoulder blade touching the scale pool. The chin up, look straight ahead. The head slider was lowered until it touches the cranium. Noted the body height in the data collection sheet (presenting in mean +/- SD, in cm). The subject must use light clothes without accessories or footwear, such as hats or hair ponytail.
Body weight
时间窗: 5 months
Body weight will be measured using Tanita RD 953-BK digital scale (presenting in mean +/- SD, in kg). The subjects were asked to step at the scale in an upright state. The body weight appears on the screen and is then noted in the data collection sheet. The subject must use light clothes without accessories or footwear
sICAM-1
时间窗: 5 months
sICAM-1 will be analyzed using Human intercellular adhesion molecule 1 Elisa kit (Bioassay Technology Laboratory) (in ng/ml). The data will be presented as mean +/- standard deviation (SD)
Endothelin-1
时间窗: 5 months
Endothelin-1 will be analyzed using the Human Endothelin-1 Elisa kit (Bioassay Technology Laboratory) (in ng/ml). The data will be presented as mean +/- standard deviation (SD)
次要结局
- Diastolic blood pressure(5 months)
- HDL-c(5 months)
- Body Mass Index (BMI)(5 months)
- Total cholesterol(5 months)
- Triglyceride(5 months)
- Systolic blood pressure(5 months)
- Fasting blood glucose(5 months)
- LDL-c(5 months)
- Fasting insulin(5 months)
研究者
Nur Aisiyah Widjaja
Principal Investigator on Nutrition and Metabolic Disease
Universitas Airlangga