Insulin Resistance Among Hepatitis C Infected Children

NCT ID: NCT07238530

Last Updated: 2025-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-30

Study Completion Date

2016-07-01

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Patient group included 60 hepatitis C infected children and adolescents

The patient group included 30 thalassemic patients and 30 malignancy survivors

No interventions assigned to this group

Control group of 30 age and sex matched healthy children and adolescents

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

3 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Pediatric Protocol

Identifier Type: OTHER

Identifier Source: secondary_id

FMASU MSO 15/2025

Identifier Type: -

Identifier Source: org_study_id

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