Effects of cold exposure on metabolism in children with fatty liver disease
Impact of Cold Exposure on Metabolic Regulation in Children With Non Alcoholic Fatty Liver Disease (NAFLD)
This study is testing if cold exposure can help improve metabolism and reduce liver fat in children with fatty liver disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 8 Years to 26 Years |
| Sex | All |
| Sponsor | Guy's and St Thomas' NHS Foundation Trust Academic / other |
| Locations | 1 site (London) |
| Trial ID | NCT04969744 on ClinicalTrials.gov |
What this trial studies
This project aims to evaluate the impact of intermittent cold exposure on brown and white adipose tissue function in children with non-alcoholic fatty liver disease (NAFLD). The study will involve two stages: the first will recruit young adults aged 16-26 to assess the effects of a cooling garment on adipose tissue activation, while the second will focus on children aged 8-16 with NAFLD and matched controls. Participants will undergo MRI scans and thermal imaging before and after cold exposure to measure changes in adipose tissue and liver fat content. Additionally, serum markers related to metabolism will be analyzed, and gut microbiome samples will be collected from NAFLD patients.
Who should consider this trial
Good fit: Ideal candidates include children aged 8-16 diagnosed with non-alcoholic fatty liver disease and healthy controls with a BMI z score less than 1.5.
Not a fit: Patients with severe underlying health conditions or those requiring medications that could affect adipose tissue function may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a non-invasive treatment option for children with NAFLD, potentially improving their metabolic health.
How similar studies have performed: While the approach of using cold exposure for metabolic regulation is novel, preliminary studies in animal models have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Stage 1: Young Adult 16-26 year olds * Individual must be aged 16-26 years * Individual who has voluntarily signed informed consent Stage 2: Children 8-16 year olds * Child aged 8-16 years old with NAFLD attending the paediatric clinic at Kings College Hospital * A control group of children with a BMI z score \<1.5 and no diagnosis of liver disease * Individual willing to participate in the study with informed consent. If the participant is under 16, the parent should provide informed consent. Exclusion Criteria: Stage 1: Young Adult 16-26 year olds * Individual who is thought to be too unwell to participate by the study team, e.g. if participant has a fever or infection requiring treatment with antibiotics. * Individual who has a medical condition that requires treatment with a drug that could alter BAT function, e.g. thyroid disease (thyroxine, carbimazole, propylthiouracil, beta- blockers), liver disease (ursodeoxycholic acid), any condition requiring treatment with peroxisome proliferator-activated receptor gamma (PPAR-γ) agonists or 4 beta 3 adrenoceptor (β3-AR) agonists. * Individual has smoked/vaped 5 days before participating in the study. Stage 2: Children 8-16 year olds * Participant who is thought to be too unwell to participate by the study team, e.g. if participant has a fever or infection requiring treatment with antibiotics. * Individual who has a medical condition that requires treatment with a drug that could alter BAT function, e.g. thyroid disease (thyroxine, carbimazole, propylthiouracil, beta- blockers), liver disease (ursodeoxycholic acid), any condition requiring treatment with peroxisome proliferator-activated receptor gamma (PPAR-γ) agonists or 4 beta 3 adrenoceptor (β3-AR) agonists * Individual has smoked/vaped 5 days before participating in the study
Where this trial is running
London
- Guy's and St Thomas' NHS Foundation Trust — London, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Caroline Ovadia, Doctor — King's College London
- Study coordinator: Caroline Ovadia, Doctor
- Email: caroline.ovadia@kcl.ac.uk
- Phone: 02078486202
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.