Low EnerGy DiEt iN Adolescents With Obesity and Type 2 Diabetes: The LEGEND Study
A Multicentre Open-Label, Feasibility Study of the Use of a Short-Term Low-Energy Diet in Adolescents With Obesity and Type-2 Diabetes Mellitus
Nottingham University Hospitals NHS Trust
73 participants
Jun 30, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria32
- 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.
- Aged 12 to 17 years old.
- BMI ≥98th 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
- 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.
- Non-LED Qualitative Interview only participants
- 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.
- Aged 12 to 17 years old.
- BMI ≥98th 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 take part in a qualitative interview alongside a parent/carer only.
- HCPs
- Registered HCP.
- Experience of delivering this trial to the adolescents.
- Willing to take part in a qualitative interview about undertaking motivational interviewing training and conducting/delivering the LED intervention study.
Exclusion Criteria28
- LED intervention
- HbA1C greater than 80mmol/mol.
- Presence of diabetes-related autoantibodies, as per local centre guidelines.
- Confirmed mono-genetic cause of obesity (e.g. SIM1 mutation) or diabetes-associated syndrome such as Prader-Willi syndrome, Bardet-Biedl or Wolfram's syndrome.
- Secondary diabetes (post bone marrow transplant/chemotherapy).
- Significant psychiatric co-morbidity.
- Breastfeeding, pregnant or planning to conceive during the LED and FR phases (female participants will be advised on need for effective contraceptive methods during the 12-month study period, section 5.1.1.10).
- Any other condition which, in the opinion of the study investigator, would make it inappropriate to undertake a period of LED. (All reasons for not approaching patients will be recorded and analysed anonymously. Cases can be discussed with the core study group if there is doubt).
- Participation in another interventional trial within 6 months.
- Informed consent and/or assent not received.
- Pre-existing retinopathy.
- Dietary avoidance (including, but not limited to, due to allergies, intolerances, religious reasons and lifestyle choices) to any ingredients in the meal replacement products, including lactose.
- Previous scoliosis repair.
- Non-LED Qualitative Interview only participants
- HbA1C greater than 80mmol/mol.
- Presence of diabetes-related autoantibodies, as per local centre guidelines.
- Confirmed mono-genetic cause of obesity (e.g. SIM1 mutation) or diabetes-associated syndrome such as Prader-Willi syndrome, Bardet-Biedl or Wolfram's syndrome.
- Secondary diabetes (post bone marrow transplant/chemotherapy).
- Significant psychiatric co-morbidity.
- Breastfeeding, pregnant or planning to conceive during the LED and FR phases (female participants will be advised on need for effective contraceptive methods during the 12-month study period, section 5.1.1.10).
- Any other condition which, in the opinion of the study investigator, would either make it inappropriate to undertake a period of LED. (All reasons for not approaching patients will be recorded and analysed anonymously. Cases can be discussed with the core study group if there is doubt).
- Participation in another interventional trial within 6 months.
- Informed consent and/or assent not received.
- Pre-existing retinopathy.
- Dietary avoidance (including, but not limited to, due to allergies, intolerances, religious reasons and lifestyle choices) to any ingredients in the meal replacement products, including lactose.
- Previous scoliosis repair.
- HCPs
- • None.
Interventions
For the first 12 weeks during the LED, participants will have 4 meal replacement products each day. The following 12 weeks consists of a gradual reintroduction of food one meal at a time, in a structured stepwise progression, under the supervision of a dietitian. They will then undergo 28 weeks of weight maintenance to see if they are able to keep their weight stable.
Semi-structured interviews with 10 of the LED participants and their relative/carer.
Semi-structured interviews with 10 participants who declined the LED, and their relative/carer.
Semi-structured interviews with 10 HCPs involved in delivery of the trial.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06572345