PhenylketonuriasNCT06718842
Walking Program in Fatty Liver Children With Phenylketonuria
A study testing walking free online supervised program in people with Phenylketonurias and Non Alcoholic Fatty Liver, run by Cairo University at 1 site in Egypt.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 9 to 12 years
- Conditions the study is for
- Phenylketonurias, Non Alcoholic Fatty Liver
- What is being tested?
- walking free online supervised program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Sep 2024to 30 Jan 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 9 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- PKU children
- obese children
- fatty liver children (non-alcoholic fatty liver)
Who cannot join
- cardiac children
- diabetic children
- neurogenic disorders
- respiratory and renal problems
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Dokki, Giza Governorate, 11432
ali AM Ismail, lecturer, +201005154209, ali.mohamed@pt.cu.edu.eg
shimaa Bondok, PHD, 02 101 565 5118, dr.shymaa_bondok@yahoo.com
About this study
Official title: Walking Program in Fatty Liver Children With Phenylketonuria: Response of Liver Enzymes
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
Read the detailed description
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
- Conditions
- Phenylketonurias, Non Alcoholic Fatty Liver
- Being tested
- walking free online supervised program
- Medical subject headings
- Phenylketonurias, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
walking free online supervised programBehavioural
this Group I will include PKU children sufferers (n=20) with non-alcoholic fatty liver that will perform walking program (online supervised free walking that will be applied daily for eight weeks)
| Study group | Role | What they receive |
|---|---|---|
| group I | Experimental | this Group I will include PKU children sufferers (n=20) with non-alcoholic fatty liver that will perform walking program (online supervised free walking that will be applied daily for eight weeks) Receives: Behavioral: walking free online supervised program |
| Group II | No intervention | this Group II will include PKU children sufferers (n=20) with non-alcoholic fatty liver that will act a waitlisted children |
What is being measured
The primary outcome is the main question the study is designed to answer.
alanine transamianse
it is a serum liver enzyme
Measured: it will be assessed after eight weeks
Secondary outcomes (5)
aspartate tranaminase
it is a serum liver enzyme
Measured: it will be assessed after eight weeks
Gamma-glutamyl Transferase
it is a serum liver enzyme
Measured: it will be assessed after eight weeks
alkaline phosphatase
it is a serum liver enzyme
Measured: it will be assessed after eight weeks
triglycerides
it will be measured in the serum
Measured: it will be assessed after eight weeks
body mass index
it will be measured after emptying bladder
Measured: it will be assessed after eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start15 Sep 2024
- Primary completion30 Jan 2025 (estimated)
- Study completion30 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PhenylketonuriasStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Mohamed Ali ismail, Cairo University
- Investigators
- Ali Ismail, lecturer, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06718842
- Sponsor's protocol ID
- P.T.REC/012/005449
- Status last verified
- Dec 2024
- First submitted
- 2 Dec 2024
- Last updated
- 5 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ali Ismail AM, Gohary MM, Mabrouk Bondok SM, Abo Elatta AB, Ahmed El Gressy NSS, El Melhat AM, El-Sayed Felaya EE. Effect of walking exercise on liver enzymes in children with phenylketonuria and non-alcoholic fatty liver disease: A randomized controlled trial. Med Clin (Barc). 2026 Apr;166(4):107395. doi: 10.1016/j.medcli.2026.107395. Epub 2026 Mar 6. English, Spanish.
PubMed 41793924
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Walking Program in Fatty Liver Children With Phenylketonuria: Response of Liver Enzymes
- ClinicalTrials.gov ID
- NCT06718842
- Acronym / sponsor ID
- P.T.REC/012/005449
- Conditions
- Phenylketonurias, Non Alcoholic Fatty Liver
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Sep 2024 (actual)
- Primary completion
- 30 Jan 2025 (estimated)
- Study completion
- 30 Jan 2025 (estimated)
- First posted
- 5 Dec 2024 (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.
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
Detailed description
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group I | Experimental | Behavioral: walking free online supervised programthis Group I will include PKU children sufferers (n=20) with non-alcoholic fatty liver that will perform walking program (online supervised free walking that will be applied daily for eight weeks) |
| Group II | No intervention | –this Group II will include PKU children sufferers (n=20) with non-alcoholic fatty liver that will act a waitlisted children |
Who may qualify
- Ages
- 9 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- PKU children
- obese children
- fatty liver children (non-alcoholic fatty liver)
Key exclusion criteria (4 listed)
- cardiac children
- diabetic children
- neurogenic disorders
- respiratory and renal problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| walking free online supervised programthis Group I will include PKU children sufferers (n=20) with non-alcoholic fatty liver that will perform walking program (online supervised free walking that will be applied daily for eight weeks) | Behavioural | group I |
Primary outcome
alanine transamianse
Time frame: it will be assessed after eight weeks
it is a serum liver enzyme
5 secondary outcomes
aspartate tranaminase
Time frame: it will be assessed after eight weeks
Gamma-glutamyl Transferase
Time frame: it will be assessed after eight weeks
alkaline phosphatase
Time frame: it will be assessed after eight weeks
triglycerides
Time frame: it will be assessed after eight weeks
body mass index
Time frame: it will be assessed after eight weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
- Derived from this study: PubMed 41793924Ali Ismail AM, Gohary MM, Mabrouk Bondok SM, Abo Elatta AB, Ahmed El Gressy NSS, El Melhat AM, El-Sayed Felaya EE. Effect of walking exercise on liver enzymes in children with phenylketonuria and non-alcoholic fatty liver disease: A randomized controlled trial. Med Clin (Barc). 2026 Apr;166(4):107395. doi: 10.1016/j.medcli.2026.107395. Epub 2026 Mar 6. English, Spanish.
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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.
Ali Ismail, lecturer study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing walking free online supervised program in people with Phenylketonurias and Non Alcoholic Fatty Liver, run by Cairo 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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 5 Dec 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ali Isamil, Lecturer (0201005154209, ali.mohamed@pt.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
alanine transamianse (time frame: it will be assessed after eight weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06718842, which also lists 1 linked publication.
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 5 Dec 2024.