CompletedNot Applicable

Insulin Resistance Among Hepatitis C Infected Children

Egypt90 participantsStarted 2015-09

Plain-language summary

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.

Who can participate

Age range

3 Years – 18 Years

Sex

ALL

See this in plain English?

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

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: over a period of 6 months

Trial details

NCT IDNCT07238530

SponsorAin Shams University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2016-05

View on ClinicalTrials.gov More This Study is to Assess Occurence of Insulin Resistance Among Hepatits C Infected Children Whether Thalassemic or Survivors of Childhood Malignancy trials