ClinicaliQ Trial Snapshot
- Low EnerGy DiEt iN Adolescents With Obesity and Type 2 Diabetes: The LEGEND Study — Recruiting • Non-phase study • Diabetes / Metabolic • NCT06572345.
- Testing: A feasibility study investigating recruitment/retention rates for low energy diet (LED) interventions in adolescents with type 2 diabetes and obesity, with measurement of weight loss needed to achieve diabetes remission.
- Patient Eligibility: Adolescents diagnosed with type 2 diabetes mellitus who also have obesity; study assesses practical recruitment and retention barriers in this population.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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…
Eligibility Snapshot
- 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…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.