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临床试验/NCT06229184
NCT06229184已完成不适用

Can Fecal Calprotectin Be Used as a Biomarker of Non-alcoholic Fatty Liver Disease In Obese Adolescents?

Sisli Hamidiye Etfal Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2022年11月16日最近更新:
适应症
干预措施

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

Experimental

Fecal calprotectin samples taken for comparison from healthy adolescents

干预措施: Fecal Calprotectin Test (Diagnostic Test)

Obese group

Experimental

Fecal calprotectin samples taken from obese adolescents

干预措施: Fecal Calprotectin Test (Diagnostic Test)

Obese + NAFLD group

Experimental

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

发起方
Sisli Hamidiye Etfal Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Busra Tetik Dincer

Resident doctor

Sisli Hamidiye Etfal Training and Research Hospital

研究点 (1)

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