Magnetic Resonance Imaging Assessment of Multiorgan Health in Obesity
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Childhood Obesity. Basic parameters: 12 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Impact of Weight Loss Interventions on Multiorgan Health, Detected by Quantitative MRI, in Children and Young People With Severe Obesity.
Overview
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.
Primary outcome measures
- Change in Liver fat measured using quantitative MRI [Time frame: From enrollment to 9 months]
Secondary outcome measures (4)
- Changes to body composition assessed by MRI [Time frame: Baseline to 9 months]
- Change in pancreatic fat assessed by MRI. [Time frame: Baseline to 9 months]
- Changes in biochemical parameters-fasting glucose [Time frame: 9 months]
- Changes in biochemical parameters-HbA1C [Time frame: 9 months]
Eligibility criteria
Inclusion criteria
- Age 12 to <18 years at the time of enrolment
- BMI >99.6th centile or >2.67 SDS
- Informed consent from parent(s) (or person with parental responsibility) and assent from the child or young person for participants aged less than 16 years (or)
- Informed consent from the participant if aged ≥ 16 years.
Exclusion criteria
- Body weight above upper limit of the scanner (>250 kilograms)
- Needs general anaesthesia for the MRI scanning
- Any contraindications for MRI- Metal implants/claustrophobia
- Previous use of GLP-1 receptor agonist
- Refusal to consent or refusal to assent from a competent older adolescent.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United Kingdom · 1 center
- Alder Hey Children's hospital — Liverpool
Identifiers
NCT: NCT07702825 · 349237