Active — Not RecruitingPhase 4

Hepatoprotective Measures for Children at High Risk of NAFLD

Egypt200 participantsStarted 2023-11-19

Plain-language summary

Non Alcoholic Fatty Liver Disease (NAFLD) is a spectrum of disease, ranging from simple fatty deposition (steatosis) to inflammation (steatohepatitis), fibrosis, cirrhosis, and end-stage liver failure. In childhood, it may be associated with a metabolic syndrome or with obesity, or even in normal children. Liver biopsy has always been the gold standard method for diagnosing and staging NAFLD. However, the urge of non-invasive biomarkers or imaging techniques has been recommended. This study will evaluate the use of the LIVERFASt biomarkers for early detection and staging of NAFLD.

Who can participate

Age range5 Years – 18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Children aged between 5-18 years, including: * Population P1: N=65 overweight (BMI between 85th \& 94th centile) and obese children (BMI = or \> 95th centile) at-risk of NAFLD * Population P2: N=65 children on maintenance therapy (High Dose Methotrexate 2.5 or 5 mg according to risk level, every other week for 4 doses and daily 6-Mercaptopurine tab. 50 mg/m2/day for 56 days) for Acute Lymphoblastic Leukemia, at risk of chemotherapy induced steatohepatitis. * Population P3: N=65 control healthy children matched for gender and age with P1\&2. Exclusion Criteria: * Conditions that could interfere with measured labs (acute/chronic hemolysis, acute hepatitis, extra hepatic cholestasis, systemic inflammatory response).

What they're measuring

Study of the prevalence of liver steatosis, steatohepatitis and fibrosis among the study population by using LIVERFASt.

Timeframe: 2 years

Trial details

NCT IDNCT06918080

SponsorAin Shams University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-05