Low EnerGy DiEt iN Adolescents With Obesity and Type 2 Diabetes: The LEGEND Study (NCT06572345) | Clinical Trial Compass
RecruitingNot Applicable
Low EnerGy DiEt iN Adolescents With Obesity and Type 2 Diabetes: The LEGEND Study
United Kingdom73 participantsStarted 2025-06-30
Plain-language summary
This is a multicentre, single-arm, feasibility study in adolescents with T2DM and obesity to investigate the recruitment and retention rates to a study using Low Energy Diets(LED). It will also provide estimates of weight loss needed to bring about remission to inform a larger randomised study. In addition a subgroup of participants and their parents/carers undertaking a period of LED will be interviewed to understand the participants experience of taking part. Two further groups will also be interviewed: participants and their parents/carers who have declined to take part in the LED to understand their motivations and barriers and healthcare practitioners who have participated in conducting the trial to understand their experience of the study.
Who can participate
Age range
12 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
LED intervention
* Diagnosis of T2DM (defined as an HbA1C ≥48mmol/mol, in the absence of features of type 1 or monogenic/syndromic diabetes).
* Current HbA1C ≥48 (or ≥42 on antidiabetic medication) and ≤ 80 mmol/mol. To allow for the day-to-day variation in HbA1C and differences between point of care laboratory tests, -2 or +2 mmol/mol in the HbA1C result will be allowed in the current criteria if one of them is between or equal to 42-80mmol/mol.
* Aged 12 to 17 years old.
* BMI ≥981st centile (+2 SD) for age and sex (UK90 growth reference data).
* Informed consent:
* Received from the young person (age 16-17) OR
* Received from young person's parent/carer, with patient assent (age 12-15).
* Willing to engage in and commit to low energy diet, FR and weight management phases including follow-up and attending study visits.
LED Intervention Interviews
The same interview inclusion criteria for LED intervention, with the following additional requirements:
Patients:
* Informed consent:
* Received from the young person (age 16-17) OR
* Received from young person's parent/carer, with patient assent (age 12-15).
* Willing to take part in a qualitative interview alongside a parent/carer.
Relative/Carer:
* A relative/carer for a young person meeting the above LED participant eligibility criteria.
* Informed consent from the relative/carer to participate in the interview.
* Willing to take part in a qualitative interview alongside the young person.
N…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of potential participants that can be recruited to an LED intervention
Timeframe: 12 months
2
Retention rate measured by by data availability for participant height.
Timeframe: 12 months
3
Retention rate measured by by data availability for participant weight.
Timeframe: 12 months
4
Retention rate measured by by data availability for participant HbA1C.