Magnetic Resonance Imaging Assessment of Multiorgan Health in Obesity

Alder Hey Children's NHS Foundation Trust30 enrolled

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Childhood Obesity

Eligibility

Sex: ALLMin age: 12 YearsMax age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

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

Central Contacts

Anand Ramakrishnan, MD (Ped), MSc (Diab), PhD endo

CONTACT

+44 01512525956 senthil.senniappan@alderhey.nhs.uk

Anand Ramakrishnan, MBBS, MD, MRCPCH, DipUKMP

CONTACT

07404613764 anand.ramakrishnan@alderhey.nsh.uk