Can Fecal Calprotectin Be Used as a Biomarker of Non-alcoholic Fatty Liver Disease In Obese Adolescents?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Fecal Calprotectin Levels
研究概览
简要总结
The incidence of non-alcoholic fatty liver disease (NAFLD) is increasing with obesity, and it is believed that ongoing inflammation in obesity and alterations in the enterohepatic axis contribute to this process. This study aimed to determine the role of fecal calprotectin (FCP) as an inflammatory biomarker in course of obesity and NAFLD.
详细描述
Obesity is a significant public health issue worldwide. With the increasing prevalence of obesity, the prevalence of metabolic syndrome in adolescents is also on the rise. Non-alcoholic fatty liver disease (NAFLD), a major cause of chronic liver disease, is the hepatic component of metabolic syndrome. The prevalence of NAFLD is not precisely known, but in some studies, it is between 22.5% and 52.8% in children with obesity, constituting 2.6% of all children. Although the mechanisms involved in the development of obesity-related metabolic complications and NAFLD are not well understood, it is believed that intestinal inflammation, changes in the microbiota, and alterations in the gut-liver axis (GLA) may play a role in the development of low-grade chronic inflammation in NAFLD associated with obesity. Fecal calprotectin (FCP), which has become increasingly important in demonstrating intestinal inflammation in recent years, is a widely used test, particularly in the diagnosis and monitoring of inflammatory bowel disease and various gastrointestinal disorders. In our study, the utility of FCP as an inflammatory biomarker in the course of NAFLD in obese adolescents has been investigated. The study was approved by our hospital's ethics committee in 15.11.2022 and another ethics committee approval was taken in 08.06.2023 for title change of study. This study conducted under the Helsinki Declaration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 18 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •10-18 years old healthy adolescents for control group
- •Children aged 10-18 years without any additional diseases, BMI>2 SD, no hepatosteatosis detected by ultrasonography (USG), and alanine aminotransferase (ALT) levels within normal limits were included in the obese group
- •Children aged 10-18 years without any additional diseases, BMI>2 SD, Hepatosteatosis detected by ultrasonography (USG), and alanine aminotransferase (ALT) levels higher than normal limits adjusted for gender were included in the obese + NAFLD group
排除标准
- •Diseases other than obesity and NAFLD
研究组 & 干预措施
Control group
Fecal calprotectin samples taken for comparison from healthy adolescents
干预措施: Fecal Calprotectin Test (Diagnostic Test)
Obese group
Fecal calprotectin samples taken from obese adolescents
干预措施: Fecal Calprotectin Test (Diagnostic Test)
Obese + NAFLD group
Fecal calprotectin samples taken from obese adolescents that have NAFLD
干预措施: Fecal Calprotectin Test (Diagnostic Test)
结局指标
主要结局
Fecal Calprotectin Levels
时间窗: Through study completion, an average of 3 months
Fecal calprotectin levels expected to be higher in obese adolescents, even higher in obese + NAFLD adolescents
次要结局
- Alanine Aminotransferase (ALT) Levels(Through study completion, an average of 3 months)
研究者
Busra Tetik Dincer
Resident doctor
Sisli Hamidiye Etfal Training and Research Hospital
