Alder Hey Children's hospital
Liverpool, Merseyside, L122AP, United Kingdom
Location status: Recruiting
NCT Number: NCT07702825
The goal of this study is to quantify the body composition and organ fat distribution changes with obesity interventions in adolescents with severe obesity. The main question the investigators aim to answer is if there is improvement in organ health with weight loss intervention. The investigators will be comparing the degree of these changes between children being treated with GLP1 receptor agonists in addition to lifestyle changes and those managed with lifestyle changes alone. Participants will undergo MRI body composition at baseline and after 9 months.
Interested in participating?
Request Info12 year–18 year
All sexes
Observational
Liverpool, Merseyside, L122AP, United Kingdom
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: From enrollment to 9 months
Change in liver fat content from baseline to follow-up, quantified using MRI-derived proton density fat fraction (PDFF).
Time frame: Baseline to 9 months
Change from baseline in Visceral adipose tissue(VAT) and Subcutaneous adipose tissue (VAT) measured in cm2 assessed by quantitative MRI
Time frame: Baseline to 9 months
Change from baseline in pancreatic fat measured as proton density fat fraction (%) assessed by quantitative MRI.
Time frame: 9 months
Changes from baseline in fasting glucose measured in mmol/l
Time frame: 9 months
Change from baseline in HbA1C measured in mmol/mol
Time frame: 9 months
Change in Apnoea Hypopnoea Index (AHI) score from baseline measured as number of events per hour.
Contact information is provided by the study sponsor or research team.
Anand Ramakrishnan, MBBS, MD, MRCPCH, DipUKMP
CONTACT
Anand Ramakrishnan, MD (Ped), MSc (Diab), PhD endo
CONTACT
Alder Hey Children's NHS Foundation Trust
Other
Impact of Weight Loss Interventions on Multiorgan Health, Detected by Quantitative MRI, in Children and Young People With Severe Obesity.
Acronym: FIT-YOUNG
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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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