This Study is to Assess Occurence of Insulin Resistance Among Hepatits C Infected Children Whether Thalassemic or Survivors of Childhood MalignancyNCT07238530
Insulin Resistance Among Hepatitis C Infected Children
An observational study of This Study is to Assess Occurence of Insulin Resistance Among Hepatits C Infected Children Whether Thalassemic or Survivors of Childhood Malignancy, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- This Study is to Assess Occurence of Insulin Resistance Among Hepatits C Infected Children Whether Thalassemic or Survivors of Childhood Malignancy
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- Sep 2015to 1 Jul 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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
Who may be able to join
- hepatitis C virus ribonucleic acid (RNA) positive children, who were following up at the pediatric hematology and oncology clinic
Who cannot join
- 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,
Show all 9Show fewer
- Wilson's disease,
- patients with obesity (BMI > 25), or
- Type 2 DM.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Pediatric hematology and Oncology clinic, Children's Hospital, Ain Shams university
Cairo
About this study
Official title: 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:
Read more
- Do children infected with Hepatitis C have a higher incidence of Insulin resistance compared to healthy controls of same age and gender?
- 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: over a period of 6 months
Secondary outcomes (1)
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study startSep 2015
- Primary completionMay 2016
- Study completion1 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for This Study is to Assess Occurence of Insulin Resistance Among Hepatits C Infected Children Whether Thalassemic or Survivors of Childhood MalignancyStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07238530
- Sponsor's protocol ID
- FMASU MSO 15/2025
- Other IDs
- Pediatric Protocol
- Status last verified
- Oct 2025
- First submitted
- 16 Nov 2025
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: this study enrolled patients before January 2019
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Insulin Resistance in Hepatitis C Infected Thalassemia Children and Survivors of Childhood Malignancy
- ClinicalTrials.gov ID
- NCT07238530
- Acronym / sponsor ID
- FMASU MSO 15/2025
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- May 2016 (actual)
- Study completion
- 1 Jul 2016 (actual)
- First posted
- 20 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Do children infected with Hepatitis C have a higher incidence of Insulin resistance compared to healthy controls of same age and gender?
- 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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – | – |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (1 listed)
- hepatitis C virus ribonucleic acid (RNA) positive children, who were following up at the pediatric hematology and oncology clinic
Key exclusion criteria (9 listed)
- patients with concurrent active hepatitis B virus infection (positive for hepatitis B surface antigen) or
- autoimmune hepatitis,
- primary biliary cirrhosis (PBC),
- sclerosing cholangitis,
- haemochromatosis,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Secondary outcome measure was to assess correlation between insulin resistance and HCV viral load and metabolic parameters.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Individual participant dataSharing planned: No. this study enrolled patients before January 2019
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of This Study is to Assess Occurence of Insulin Resistance Among Hepatits C Infected Children Whether Thalassemic or Survivors of Childhood Malignancy, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.