Magnetic Resonance Imaging Assessment of Multiorgan Health in Obesity

ConditionChildhood Obesity

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age12-18

SponsorAlder Hey Children's NHS Foundation Trust

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial population

Eligible adolescents under the care of the tertiary weight management service (Complications from Excess Weight service) at Alder Hey Children's hospital will be offered to enrol in the study once a decision has been taken whether or not they are being started on GLP1 receptor agonist treatment.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

30 Participants

are grouped into 2 trial groups

Group A: Patients on GLP1 receptor agonist

Group B: Patients not on GLP1 receptor agonist

Trial outcomes

Primary outcomes

Change in Liver fat measured using quantitative MRI

Change in liver fat content from baseline to follow-up, quantified using MRI-derived proton density fat fraction (PDFF).

Time frame

From enrollment to 9 months

Secondary outcomes

Changes to body composition assessed by MRI

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 in pancreatic fat assessed by MRI.

Change from baseline in pancreatic fat measured as proton density fat fraction (%) assessed by quantitative MRI.

Time frame

Baseline to 9 months

Changes in biochemical parameters-fasting glucose

Changes from baseline in fasting glucose measured in mmol/l

Time frame

9 months

Changes in biochemical parameters-HbA1C

Change from baseline in HbA1C measured in mmol/mol

Time frame

9 months

Other outcomes

Change in sleep study parameter

Change in Apnoea Hypopnoea Index (AHI) score from baseline measured as number of events per hour.

Time frame

9 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Alder Hey Children's NHS Foundation Trust

Lead sponsor

Source ClinicalTrials.gov

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