Status:
RECRUITING
Low EnerGy DiEt iN Adolescents With Obesity and Type 2 Diabetes: The LEGEND Study
Lead Sponsor:
Nottingham University Hospitals NHS Trust
Collaborating Sponsors:
Diabetes UK
Conditions:
Pediatric Obesity
Type 2 Diabetes
Eligibility:
All Genders
12-17 years
Phase:
NA
Brief 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 provid...
Detailed Description
LED intervention The three-stage intervention, will be delivered by the local study dietitian and doctor. Participants will typically undergo a 12-week intensive LED intervention followed by a 12-wee...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
June 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT06572345
Start Date
June 30 2025
End Date
December 31 2026
Last Update
August 3 2025
Active Locations (1)
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1
Nottingham University Hospital NHS Trust
Nottingham, United Kingdom, NG7 2UH