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

NCT06229184 | Completed DMC

• 1 other identifier: 15.11.2022-2124
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity, Childhood; NAFLD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Alanine Aminotransferase (ALT) Levels

  Through study completion, an average of 3 months

Study Arms (3)

Control group

EXPERIMENTAL

Fecal calprotectin samples taken for comparison from healthy adolescents

Diagnostic Test: Fecal Calprotectin Test

Obese group

EXPERIMENTAL

Fecal calprotectin samples taken from obese adolescents

Diagnostic Test: Fecal Calprotectin Test

Obese + NAFLD group

EXPERIMENTAL

Fecal calprotectin samples taken from obese adolescents that have NAFLD

Diagnostic Test: Fecal Calprotectin Test

Interventions

Fecal Calprotectin Test DIAGNOSTIC_TEST

Fecal samples are taken fom obese and healthy adolescents for study

Control group; Obese + NAFLD group; Obese group

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Diseases other than obesity and NAFLD

Sponsors & Collaborators

• Sisli Hamidiye Etfal Training and Research Hospital: lead

Study Sites (1)

Sisli Hamidiye Etfal Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

• Dincer BT, Usta AM, Kural A, Helvaci N, Ucar A, Urganci N. Can fecal calprotectin be used as a biomarker of non-alcoholic fatty liver disease in obese adolescents? BMC Pediatr. 2024 Dec 23;24(1):834. doi: 10.1186/s12887-024-05327-4.

  PMID: 39716084 DERIVED

MeSH Terms

Conditions

Pediatric Obesity; Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Ayşe Merve Usta, M.D.

  Sisli Hamidiye Etfal Training and Research Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident doctor

Study Record Dates

• First Submitted: January 9, 2024
• First Posted: January 29, 2024
• Study Start: November 16, 2022
• Primary Completion: August 10, 2023
• Study Completion: August 10, 2023
• Last Updated: February 13, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)