Actively Recruiting
Low EnerGy DiEt iN Adolescents With Obesity and Type 2 Diabetes: The LEGEND Study
Led by Nottingham University Hospitals NHS Trust · Updated on 2025-08-03
73
Participants Needed
1
Research Sites
78 weeks
Total Duration
On this page
Sponsors
N
Nottingham University Hospitals NHS Trust
Lead Sponsor
D
Diabetes UK
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Low EnerGy DiEt iN Adolescents With Obesity and Type 2 Diabetes: The LEGEND Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with type 2 diabetes mellitus (HbA1C ≥48 mmol/mol without features of type 1 or monogenic/syndromic diabetes)
- Current HbA1C between 48 and 80 mmol/mol, or between 42 and 80 mmol/mol if on antidiabetic medication
- Aged 12 to 17 years
- BMI at or above the 98th percentile (+2 SD) for age and sex based on UK90 growth reference data
- Informed consent received from the young person (if 16-17 years old) or from parent/carer with patient assent (if 12-15 years old)
- Willingness to engage in and commit to the low energy diet, food reintroduction, weight management phases, follow-up, and study visits
You will not qualify if you...
- HbA1C greater than 80 mmol/mol
- Presence of diabetes-related autoantibodies as per local guidelines
- Confirmed monogenic cause of obesity or diabetes-associated syndromes (e.g., Prader-Willi, Bardet-Biedl, Wolfram's syndrome)
- Secondary diabetes due to bone marrow transplant or chemotherapy
- Significant psychiatric co-morbidity
- Breastfeeding, pregnant, or planning pregnancy during the LED and food reintroduction phases
- Any condition deemed inappropriate for LED by the investigator
- Participation in another interventional trial within the past 6 months
- Informed consent and/or assent not received
- Pre-existing retinopathy
- Dietary avoidance of ingredients in meal replacement products, including lactose
- Previous scoliosis repair
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Nottingham University Hospital NHS Trust
Nottingham, United Kingdom, NG7 2UH
Actively Recruiting
Research Team
P
Pooja Sachdev, MD
CONTACT
G
Gemma Boam, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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