Walking Program in Fatty Liver Children With Phenylketonuria

December 2, 2024 updated by: Ali Mohamed Ali ismail, Cairo University

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: group I
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)
Behavioral: walking free online supervised program
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)
No Intervention: Group II
this Group II will include PKU children sufferers (n=20) with non-alcoholic fatty liver that will act a waitlisted children

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
alanine transamianse
Time Frame: it will be assessed after eight weeks
it is a serum liver enzyme
it will be assessed after eight weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
aspartate tranaminase
Time Frame: it will be assessed after eight weeks
it is a serum liver enzyme
it will be assessed after eight weeks
Gamma-glutamyl Transferase
Time Frame: it will be assessed after eight weeks
it is a serum liver enzyme
it will be assessed after eight weeks
alkaline phosphatase
Time Frame: it will be assessed after eight weeks
it is a serum liver enzyme
it will be assessed after eight weeks
triglycerides
Time Frame: it will be assessed after eight weeks
it will be measured in the serum
it will be assessed after eight weeks
body mass index
Time Frame: it will be assessed after eight weeks
it will be measured after emptying bladder
it will be assessed after eight weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Chair: Ali Ismail, lecturer, Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2024

Primary Completion (Estimated)

January 30, 2025

Study Completion (Estimated)

January 30, 2025

Study Registration Dates

First Submitted

December 2, 2024

First Submitted That Met QC Criteria

December 2, 2024

First Posted (Estimated)

December 5, 2024

Study Record Updates

Last Update Posted (Estimated)

December 5, 2024

Last Update Submitted That Met QC Criteria

December 2, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P.T.REC/012/005449

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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