Low-energy diet program for teens with obesity and type 2 diabetes (LEGEND)
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
This study will try a 12-week low-energy meal-replacement diet followed by structured food reintroduction and maintenance in teens with obesity and type 2 diabetes to see if weight loss can lead to diabetes remission.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 73 (estimated) |
| Ages | 12 Years to 17 Years |
| Sex | All |
| Sponsor | Nottingham University Hospitals NHS Trust Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Nottingham) |
| Trial ID | NCT06572345 on ClinicalTrials.gov |
What this trial studies
This multicentre single-arm feasibility study will deliver a three-stage low-energy diet program to adolescents (12–17 years) with obesity and type 2 diabetes. Participants will typically complete a 12-week total meal-replacement low-energy diet (800–1000 kcal/day), a 12-week food reintroduction phase, and then a weight maintenance phase, with a target loss of 15 kg or 15% of starting weight if <80 kg. The study will measure recruitment and retention rates and estimate the amount of weight loss needed to achieve diabetes remission defined as HbA1c <48 mmol/mol measured three months apart. Qualitative interviews with participants, parents/carers who accept or decline the LED, and participating healthcare professionals will explore experiences, motivations, and barriers.
Who should consider this trial
Good fit: Adolescents aged 12–17 with obesity (BMI ≥98th percentile for age/sex) and type 2 diabetes with an HbA1c ≥48 mmol/mol (or ≥42 mmol/mol if on diabetes medication) and ≤80 mmol/mol who are willing to follow a strict low-energy diet and attend follow-up visits.
Not a fit: Patients with type 1 or monogenic diabetes, those unable or unwilling to adhere to meal replacements and structured follow-up, or those with HbA1c or weight outside the eligibility range are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the approach could allow some teenagers to lose enough weight to put their type 2 diabetes into remission and reduce or stop diabetes medications.
How similar studies have performed: Similar total meal‑replacement low-energy programs have produced diabetes remission in adults (e.g., DiRECT) and have safety data in young people, but controlled evidence specifically in adolescents with T2DM remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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. * 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 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. 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 criteria 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.
Where this trial is running
Nottingham
- Nottingham University Hospital NHS Trust — Nottingham, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Pooja Sachdev, MD
- Email: pooja.sachdev@nhs.net
- Phone: 0115 924 9924
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.