Completed

NCT Number: NCT07238530

Insulin Resistance Among Hepatitis C Infected Children

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.

Completed

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Key information

Conditions

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

Age range

3 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Cairo, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

Time frame: over a period of 6 months

Insulin resistance was assessed by using Homeostasis Model Assessment (HOMA) index

Secondary outcomes

Secondary outcome measure was to assess correlation between insulin resistance and HCV viral load and metabolic parameters.

Time frame: 6 months

HCV viral load was measured by HCV RNA level by PCR, and metabolic parameters included liver functions, serum ferritin, fasting glucose and fasting insulin

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: Nov 20, 2025
Registry last updated: Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.