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

NAFLD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06229184
• Other study ID #: 15.11.2022-2124
• Status: Completed
• Phase: N/A
• Start date: November 16, 2022
• Est. completion date: August 10, 2023

Study information

• Verified date: February 2024
• Source: Sisli Hamidiye Etfal Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: August 10, 2023
• Est. primary completion date: August 10, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Diseases other than obesity and NAFLD

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• NAFLD
• Non-alcoholic Fatty Liver Disease
• Obesity, Childhood
• Pediatric Obesity

Intervention

Diagnostic Test:
• Fecal Calprotectin Test
Fecal samples are taken fom obese and healthy adolescents for study

Locations

Country	Name	City	State
Turkey	Sisli Hamidiye Etfal Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Sisli Hamidiye Etfal Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fecal Calprotectin Levels	Fecal calprotectin levels expected to be higher in obese adolescents, even higher in obese + NAFLD adolescents	Through study completion, an average of 3 months
Secondary	Alanine Aminotransferase (ALT) Levels	ALT levels expected to be higher in NAFLD adolescents	Through study completion, an average of 3 months