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

S

Sisli Hamidiye Etfal Training and Research Hospital

Status

Completed

Conditions

Obesity, Childhood
NAFLD

Treatments

Diagnostic Test: Fecal Calprotectin Test

Study type

Interventional

Funder types

Other

Identifiers

NCT06229184
15.11.2022-2124

Details and patient eligibility

About

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.

Full 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.

Enrollment

41 patients

Sex

All

Ages

10 to 18 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Screening

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

41 participants in 3 patient groups

Control group
Experimental group
Description:
Fecal calprotectin samples taken for comparison from healthy adolescents
Treatment:
Diagnostic Test: Fecal Calprotectin Test
Obese group
Experimental group
Description:
Fecal calprotectin samples taken from obese adolescents
Treatment:
Diagnostic Test: Fecal Calprotectin Test
Obese + NAFLD group
Experimental group
Description:
Fecal calprotectin samples taken from obese adolescents that have NAFLD
Treatment:
Diagnostic Test: Fecal Calprotectin Test

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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