Insulin Resistance Among Hepatitis C Infected Children

Evaluation of Insulin Resistance in Hepatitis C Infected Thalassemia Children and Survivors of Childhood Malignancy

The goal of this observational study was to study the occurrence of insulin resistance in hepatitis C virus infected children who were either thalassemic or survivors of childhood malignancy and its correlation to the HCV viral load and other metabolic factors.

The main question it aims to answer is:

1. Do children infected with Hepatitis C have a higher incidence of Insulin resistance compared to healthy controls of same age and gender?
2. Is Insulin resistance occurence affected by HCV viral load, blood transfusion frequency, or metabolic factors? Researchers will compare hepatitis c infected children who are either thalassemic or survivors of childhood malignant to healthy age and sex matched controls.

Participants will be subjected to:

• standardized Questionnaires,
• physical examination and
• laboratory investigations including liver functions (ALT, AST, Alkaline phosphatase), Prothrombin time, serum ferritin level, albumin, fasting glucose, fasting insulin level and Insulin resistance assessment by HOMA IR calculation.

Study Overview

• Status: Completed
• Conditions: This Study is to Assess Occurence of Insulin Resistance Among Hepatits C Infected Children Whether Thalassemic or Survivors of Childhood Malignancy

• Study Type: Observational
• Enrollment (Actual): 90

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Pediatric hematology and Oncology clinic, Children's Hospital, Ain Shams university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patient group: Hepatitis C infected children and adolescents who are either thalassemia patients or survivors of childhood malignancy.

Control group: Age and sex matched healthy children and adolescents who are following up at pediatric outpatient clinic

Description

Inclusion Criteria:

• hepatitis C virus ribonucleic acid (RNA) positive children, who were following up at the pediatric hematology and oncology clinic

Exclusion Criteria:

• patients with concurrent active hepatitis B virus infection (positive for hepatitis B surface antigen) or
• autoimmune hepatitis,
• primary biliary cirrhosis (PBC),
• sclerosing cholangitis,
• haemochromatosis,
• α1-antitrypsin deficiency,
• Wilson's disease,
• patients with obesity (BMI > 25), or
• Type 2 DM.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Patient group included 60 hepatitis C infected children and adolescents; The patient group included 30 thalassemic patients and 30 malignancy survivors
Control group of 30 age and sex matched healthy children and adolescents

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The primary outcome measure was to study the occurrence of insulin resistance in hepatitis C virus infected children who were either thalassemic or survivors of childhood malignancy	Insulin resistance was assessed by using Homeostasis Model Assessment (HOMA) index	over a period of 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary outcome measure was to assess correlation between insulin resistance and HCV viral load and metabolic parameters.	HCV viral load was measured by HCV RNA level by PCR, and metabolic parameters included liver functions, serum ferritin, fasting glucose and fasting insulin	6 months

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2015
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: November 16, 2025
• First Submitted That Met QC Criteria: November 16, 2025
• First Posted (Actual): November 20, 2025

Study Record Updates

• Last Update Posted (Actual): November 20, 2025
• Last Update Submitted That Met QC Criteria: November 16, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: FMASU MSO 15/2025; Pediatric Protocol (Other Identifier: Faculty of Medicine Ain Shams University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: this study enrolled patients before January 2019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No