ClinicalTrials.gov record NCT06718842
Walking Program in Fatty Liver Children With Phenylketonuria
Walking Program in Fatty Liver Children With Phenylketonuria: Response of Liver Enzymes
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AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
A randomized study that compares a daily, online supervised walking program for eight weeks with a waitlist group. It is aimed at children with phenylketonuria (PKU) who also have non-alcoholic fatty liver. Main measurements are blood liver enzymes and body mass index at the end of the eight-week study period.
What it is studying. The study tests whether an 8-week, daily supervised walking program changes liver enzyme levels (alanine transaminase and others), blood triglycerides, and body mass index in children with PKU and non-alcoholic fatty liver compared with a waitlisted group.
What the researchers hope to learn. To learn whether daily supervised walking for eight weeks changes serum alanine transaminase (ALT) and other liver enzymes (AST, GGT, alkaline phosphatase), serum triglycerides, and body mass index in children with PKU and non-alcoholic fatty liver.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
phenylketonuria (commonly known as PKU) is an inherited disorder that increases the levels of a substance called phenylalanine in the blood. PKU is usually associated with many metabolic complication including non-alcoholic fatty liver
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Behavioral
- walking free online supervised program
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- PKU children
- obese children
- fatty liver children (non-alcoholic fatty liver)
Exclusion criteria
- cardiac children
- diabetic children
- neurogenic disorders
- respiratory and renal problems
Study description and what participation involves
The study's detailed description, as published on ClinicalTrials.gov.
Detailed description from the registry
this study will include PKU children sufferers 9n=40) with non-alcoholic fatty liver to be randomly assigned to group I (n=20) that will perform walking program (online supervised free walking that will be applied daily for eight weeks) or group II (N=20) that will act as waitlisted children
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
Participants are randomly assigned to one of two groups. One group will follow an online supervised walking program daily for eight weeks; the other group is waitlisted and does not receive the walking program during the study period. Researchers will measure liver enzymes (alanine transaminase, aspartate transaminase, gamma‑glutamyl transferase, alkaline phosphatase), blood triglycerides, and body mass index (BMI — measured after emptying the bladder) at the end of the eight weeks.
How the study is structured. Participants are randomly assigned to one of two groups: an active group that does an online supervised walking program daily for eight weeks, or a waitlist group that does not start the program during the study period. The study is parallel-group and single-masked. Blood tests for liver enzymes and triglycerides and measurements of body mass index are taken and compared after eight weeks.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- The listed sites are in Egypt. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on phenylketonuria
Important dates
- Study start
- Sep 15, 2024
- Primary completion
- Jan 30, 2025 (estimated)
- Study completion
- Jan 30, 2025 (estimated)
- Target enrollment
- 40 participants (estimated)
- Last updated on registry
- Dec 5, 2024
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Cairo University
- Principal investigator
- Ali Mohamed Ali ismail, Department of Physical Therapy for Cardiovascular/Respiratory Disorder and Geriatrics, Faculty of Physical Therapy
Cairo University
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Ali Isamil, Lecturer 📞 0201005154209 ✉ ali.mohamed@pt.cu.edu.eg
- shimaaa bondok, PHD 📞 02 101 565 5118 ✉ dr.shymaa_bondok@yahoo.com
Participating sites (1)
- Cairo UniversityRecruiting
Dokki, Giza Governorate, 11432 · Egypt
- ali AM Ismail, lecturer · +201005154209 · ali.mohamed@pt.cu.edu.eg
- shimaa Bondok, PHD · 02 101 565 5118 · dr.shymaa_bondok@yahoo.com
Terms used on this page · explanations by MedicalUpdates.ai
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
- randomly assigned
- Participants are assigned to the study groups by chance, like a coin toss, rather than chosen by the doctor or the participant. This is done so the groups are comparable.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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