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NCT Number: NCT06718842

Walking Program in Fatty Liver Children With Phenylketonuria

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

Recruiting

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Key information

Conditions

Phenylketonurias Amino Acid Metabolism, Inborn Errors Brain Diseases Brain Diseases, Metabolic Brain Diseases, Metabolic, Inborn Central Nervous System Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Fatty Liver Genetic Diseases, Inborn Liver Diseases Metabolic Diseases Metabolism, Inborn Errors Nervous System Diseases Non Alcoholic Fatty Liver Non-alcoholic Fatty Liver Disease Nutritional and Metabolic Diseases

Age range

9 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

walking free online supervised program

Behavioral

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)

Primary outcomes

  1. alanine transamianse

    Time frame: it will be assessed after eight weeks

    it is a serum liver enzyme

Secondary outcomes

  1. aspartate tranaminase

    Time frame: it will be assessed after eight weeks

    it is a serum liver enzyme

  2. Gamma-glutamyl Transferase

    Time frame: it will be assessed after eight weeks

    it is a serum liver enzyme

  3. alkaline phosphatase

    Time frame: it will be assessed after eight weeks

    it is a serum liver enzyme

  4. triglycerides

    Time frame: it will be assessed after eight weeks

    it will be measured in the serum

  5. body mass index

    Time frame: it will be assessed after eight weeks

    it will be measured after emptying bladder

Study contacts

Contact information is provided by the study sponsor or research team.

Ali Isamil, Lecturer

CONTACT

[email protected]

0201005154209

shimaaa bondok, PHD

CONTACT

[email protected]

02 101 565 5118

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Walking Program in Fatty Liver Children With Phenylketonuria: Response of Liver Enzymes

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 5, 2024
Registry last updated
Dec 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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