Low EnerGy DiEt iN Adolescents With Obesity and Type 2 Diabetes: The LEGEND Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-17
SponsorNottingham University Hospitals NHS Trust
About this trial
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 criteria
Qualifiers
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).
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Low-energy diet
- Qualitive interview - LED participants
- Qualitive interview - Participants declining LED
- Qualitive interview - Health Care Professionals (HCPs)
Treatment groups
73 Participants
are divided into 1 treatment groupSponsors and collaborators
Nottingham University Hospitals NHS Trust
Lead sponsor
Diabetes UK
Collaborator
Source ClinicalTrials.gov