Impact of Cold Exposure on Metabolic Regulation in Children With Non Alcoholic Fatty Liver Disease (NAFLD)

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The aim of this project is to generate pilot data for a grant proposal to evaluate the impact of intermittent cold exposure (ICE) on brown and white adipose tissue (BAT/WAT) function in children with non-alcoholic fatty liver disease (NAFLD). The condition NAFLD is the most common liver disease in both adults and children. There are many emerging drug therapies for NAFLD but at considerable cost in terms of potential side effects. In a mouse model of diet-induced obesity, ICE was shown to help activate BAT, which may help NAFLD and other obesity associated health risks. Given that children have more BAT than adults, we hypothesise that intermittent cold exposure via a cooling vest in children with NAFLD will increase BAT stores or function. We will investigate whether intermittent cold exposure via a cooling vest device will stimulate BAT and also establish whether the cooling vest is acceptable to children and young people. If it is acceptable and has an impact on BAT function this could be a new treatment to reduce the severity of metabolic disorders associated with obesity, particularly fatty liver, e.g. hepatic steatosis. In stage 1, we will investigate the impact of intermittent cold exposure (ICE) on brown and white adipose tissue (BAT/WAT) function in young people aged 16 to 26 years old, as a feasibility study to optimise the cooling process. In stage 2, we will investigate the impact of ICE on BAT and WAT function in 8-16 year olds with non-alcoholic fatty liver disease (NAFLD) and matched controls. Participants will have thermal imaging, MRI scans and provide samples before and after wearing the cooling vest.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 8
Maximum Age: 26
Healthy Volunteers: t
View:

⁃ 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.

Locations
Other Locations
United Kingdom
Guy's and St Thomas' NHS Foundation Trust
RECRUITING
London
Contact Information
Primary
Caroline Ovadia, Doctor
caroline.ovadia@kcl.ac.uk
02078486202
Backup
Dharshene Shivapatham, Masters
Dharshene.shivapatham@gstt.nhs.uk
02071887188
Time Frame
Start Date: 2021-10-23
Estimated Completion Date: 2024-12
Participants
Target number of participants: 36
Treatments
Experimental: Intermittent Cold Exposure (ICE)
Stage 1- healthy volunteers aged 16-26 years will receive ICE for one day. stage 2a - controls aged 8-16 will receive ICE for one day. Stage 2b- NAFLD patients aged 8-16 years will receive ICE for one day or choose to continue for 5 days.
Authors
Catherine Williamson
Related Therapeutic Areas
Sponsors
Collaborators: Medical Research Council, Guts UK, King's College London
Leads: Guy's and St Thomas' NHS Foundation Trust

This content was sourced from clinicaltrials.gov