Childhood ObesityFIT-YOUNGNCT07702825
Magnetic Resonance Imaging Assessment of Multiorgan Health in Obesity
An observational study of Childhood Obesity, run by Alder Hey Children's NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Childhood Obesity
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Mar 2026to Jan 2028
- How long will I take part?
- 9 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Anand Ramakrishnan, MD (Ped), MSc (Diab), PhD endo contact
United Kingdom1 site, 1 recruiting
- Recruiting
Alder Hey Children's hospital
Liverpool, Merseyside, L122AP
Anand Ramakrishnan, MBBS, MD, MRCPCH, DipUKMP, 07404613764, anand.ramakrishnan@alderhey.nhs.uk
About this study
Official title: Impact of Weight Loss Interventions on Multiorgan Health, Detected by Quantitative MRI, in Children and Young People With Severe Obesity.
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.
- Conditions
- Childhood Obesity
- Keywords
- Obesity, GLP1 receptor agonist, MRI Body composition
- Medical subject headings
- Pediatric Obesity, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients on GLP1 receptor agonist | Patients being treated with GLP1 receptor agonist in addition to lifestyle interventions | |
| Patients not on GLP1 receptor agonist | Patients not being treated with GLP1 receptor agonist and only on lifestyle intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From enrollment to 9 months
Secondary outcomes (4)
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
Measured: 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.
Measured: Baseline to 9 months
Changes in biochemical parameters-fasting glucose
Changes from baseline in fasting glucose measured in mmol/l
Measured: 9 months
Changes in biochemical parameters-HbA1C
Change from baseline in HbA1C measured in mmol/mol
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start6 Mar 2026
- Primary completionDec 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 9 Months
Sponsor and investigators
- Lead sponsor
- Alder Hey Children's NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07702825
- Sponsor's protocol ID
- 349237
- Acronym
- FIT-YOUNG
- Status last verified
- Jul 2026
- First submitted
- 1 Jul 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Weight Loss Interventions on Multiorgan Health, Detected by Quantitative MRI, in Children and Young People With Severe Obesity.
- ClinicalTrials.gov ID
- NCT07702825
- Acronym / sponsor ID
- FIT-YOUNG / 349237
- Conditions
- Childhood Obesity
- Keywords
- Obesity, GLP1 receptor agonist, MRI Body composition
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Alder Hey Children's NHS Foundation TrustUniversity, hospital or other
- Study start
- 6 Mar 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 14 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 9 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients on GLP1 receptor agonist | – | –Patients being treated with GLP1 receptor agonist in addition to lifestyle interventions |
| Patients not on GLP1 receptor agonist | – | –Patients not being treated with GLP1 receptor agonist and only on lifestyle intervention |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Liver fat measured using quantitative MRI
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).
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anand Ramakrishnan, MD (Ped), MSc (Diab), PhD endo contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Childhood Obesity, run by Alder Hey Children's NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anand Ramakrishnan, MD (Ped), MSc (Diab), PhD endo (+44 01512525956, senthil.senniappan@alderhey.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Liver fat measured using quantitative MRI (time frame: From enrollment to 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.