Low EnerGy DiEt iN Adolescents With Obesity and Type 2 Diabetes: The LEGEND Study
NCT Number: NCT06572345
Acronym: LEGEND
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pediatric Obesity|Type 2 Diabetes
Interventions: DIETARY_SUPPLEMENT: Low-energy diet|OTHER: Qualitive interview - LED participants|OTHER: Qualitive interview - Participants declining LED|OTHER: Qualitive interview - Health Care Professionals (HCPs)
Sponsor: Nottingham University Hospitals NHS Trust
Collaborators: Diabetes UK
Sex: ALL
Age: CHILD
Enrollment: 73
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2026-12-31
Locations: Nottingham University Hospital NHS Trust, Nottingham, NG7 2UH, United Kingdom

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.

Primary Outcome Measures: Proportion of potential participants that can be recruited to an LED intervention, Number of eligible participants identified compared to those consented, passed screening and started on LED intervention., 12 months|Retention rate measured by by data availability for participant height., Height obtained for the participant at:

1. End of LED phase (12 weeks)
2. End of FR phase (24 weeks)
3. End of maintenance phase (12 months), 12 months|Retention rate measured by by data availability for participant weight., Weight obtained for the participant at:

1. End of LED phase (12 weeks)
2. End of FR phase (24 weeks)
3. End of maintenance phase (12 months), 12 months|Retention rate measured by by data availability for participant HbA1C., HbA1C obtained for the participant at:

1. End of LED phase (12 weeks)
2. End of FR phase (24 weeks)
3. End of maintenance phase (12 months), 12 months
Secondary Outcome Measures: Proportion of participants that adhere to the LED, Defined by at least 5% weight loss at end of LED phase compared to baseline., 12 weeks|Degree of weight loss achieved in those who adhere to the LED and if this is maintained at 12-months., Weight as measured at end of LED phase (12 weeks), compared against weight as measured at baseline.

Weight as measured at end of FR phase (24 weeks), compared against weight as measured at baseline.

Weight as measured at end of maintenance (12 months) compared against weight at baseline., 12 months|Do those who adhere to the LED achieve remission? To determine the standard deviation of the proportion of participants that achieve remission (to estimate the sample size for a definitive randomised trial)., Percentage weight loss in those who achieve remission of T2DM defined as an HbA1C \<48 mmol/mol on two occasions at least 3 months apart, in the absence of anti-diabetes medication. This will help to determine the standard deviation of the proportion of participants that achieve remission, to enable an estimation of sample size for a future, definitive, randomised control trial., 12 months|Do those who adhere to the LED achieve remission? To determine the standard deviation of the proportion of participants that achieve remission (to estimate the sample size for a definitive randomised trial)., Absolute weight loss in those who achieve remission of T2DM defined as an HbA1C \<48 mmol/mol on two occasions at least 3 months apart, in the absence of anti-diabetes medication. This will help to determine the standard deviation of the proportion of participants that achieve remission, to enable an estimation of sample size for a future, definitive, randomised control trial., 12 months|Adverse effects, Collection of adverse events at every study visit., 12 months|Is the study, including the intervention, investigations and assessments, deliverable consistently across different sites using the standardised study resources., Qualitative interviews with patients and carers (patient and carers interviewed together) who participate in the LED, and those who do not., 12 months|Is the study, including the intervention, investigations and assessments, deliverable consistently across different sites using the standardised study resources., Qualitative interviews with healthcare professionals who are involved in delivering the study., 12 months|Which biomarkers and pathways are upregulated and which are downregulated in young people with T2DM and what is the response to an LED intervention., Understanding the pattern of and metabolic changes in:

• water soluble metabolites before (at baseline) and after following a LED (at end of LED - 12 weeks, end of FR -24 weeks and end of WM - 12 months)., 12 months|Which biomarkers and pathways are upregulated and which are downregulated in young people with T2DM and what is the response to an LED intervention., Understanding the pattern of and metabolic changes in:

• lipid metabolites before (at baseline) and after following a LED (at end of LED - 12 weeks, end of FR -24 weeks and end of WM - 12 months)., 12 months|What are the positive and potential negative effects of a period of LED on the biological wellbeing of adolescents., Changes in clinical markers, such as blood pressure, including both systolic and diastolic measurements (mmHg)., 12 months|What are the positive and potential negative effects of a period of LED on the biological wellbeing of adolescents., HbA1C, 12 months|What are the positive and potential negative effects of a period of LED on the biological wellbeing of adolescents., Full Blood Count, 12 months|What are the positive and potential negative effects of a period of LED on the biological wellbeing of adolescents., Ferritin, 12 months|What are the positive and potential negative effects of a period of LED on the biological wellbeing of adolescents., White Blood Cell Count, 12 months|What are the positive and potential negative effects of a period of LED on the biological wellbeing of adolescents., Platelet count, 12 months|What are the positive and potential negative effects of a period of LED on the biological wellbeing of adolescents., Urea and electrolytes, 12 months|What are the positive and potential negative effects of a period of LED on the biological wellbeing of adolescents., alanine transaminase (ALT), 12 months|What are the positive and potential negative effects of a period of LED on the biological wellbeing of adolescents., Aspartate Transferase (AST), 12 months|What are the positive and potential negative effects of a period of LED on the biological wellbeing of adolescents., Gamma Glutamyl Transferase (GGT), 12 months|What are the positive and potential negative effects of a period of LED on the biological wellbeing of adolescents., Albumin, 12 months|What are the positive and potential negative effects of a period of LED on the biological wellbeing of adolescents., Lipid Profile - Cholesterol, triglycerides, low density lipoprotein, high density lipoprotein (all mg/DL), 12 months|What are the positive and potential negative effects of a period of LED on the biological wellbeing of adolescents., Bone profile - Parathyroid hormone (PTH), 12 months|What are the positive and potential negative effects of a period of LED on the biological wellbeing of adolescents., Bone profile - Calcium and Phosphate (mmol), 12 months|What are the positive and potential negative effects of a period of LED on the biological wellbeing of adolescents., Bone profile - Alkaline Phosphatase (ALP) (U/L), 12 months|What are the positive and potential negative effects of a period of LED on the biological wellbeing of adolescents., Bone profile - Vitamins A and E (ummol/L), 12 months|What are the positive and potential negative effects of a period of LED on the biological wellbeing of adolescents., Bone profile - Vitamin D (nmol/L), 12 months|What are the positive and potential negative effects of a period of LED on the biological wellbeing of adolescents., Bone profile - Vitamin K - prothrombin time, 12 months|What are the positive and potential negative effects of a period of LED on the biological wellbeing of adolescents., Bone profile - Vitamin K - International Normalised Ratio, 12 months|What are the positive and potential negative effects of a period of LED on the biological wellbeing of adolescents., Thyroid function tests - T3 and T4 (pmol/L), 12 months|What are the positive and potential negative effects of a period of LED on the biological wellbeing of adolescents., Thyroid function tests - Thyroid Stimulating Hormone (TSH) (mU/L), 12 months|What are the positive and potential negative effects of a period of LED on the biological wellbeing of adolescents., luteinizing hormone (LH), follicle stimulating hormone (FSH) (u/L), 12 months|What are the positive and potential negative effects of a period of LED on the biological wellbeing of adolescents., Testosterone, sex hormone binding globulin (nmol/L), 12 months|What are the positive and potential negative effects of a period of LED on the biological wellbeing of adolescents., Oestradiol (pmol/L), 12 months|What are the positive and potential negative effects of a period of LED on the biological wellbeing of adolescents., Changes in imaging markers such as liver fat on MRI, 12 months|What are the positive and potential negative effects of a period of LED on the biological wellbeing of adolescents., Changes in metabolic disease based on DXA scan, 12 months|What are the positive and potential negative effects of a period of LED on the biological wellbeing of adolescents., Changes in bone mineral density based on DXA scan, 12 months|What are the positive and potential negative effects of a period of LED on the biological wellbeing of adolescents., Changes in body composition based on DXA scan, 12 months|What are the positive and potential negative effects of a period of LED on the psychological wellbeing of adolescents., Change in eating disorder score or development of eating disorders and binge eating, assessed via the Eating Disorder Examination Questionnaire EDE-Q/EDE-A., 12 months|What are the positive and potential negative effects of a period of LED on the psychological wellbeing of adolescents., Change in psychological outcomes via the Generalised Anxiety Disorder Assessment (GAD-7)., 12 months|What are the positive and potential negative effects of a period of LED on the psychological wellbeing of adolescents., Change in psychological outcomes via the Revised Children's Anxiety and Depression Scale (RCAS)., 12 months|What are the positive and potential negative effects of a period of LED on the social wellbeing of adolescents., Change in health-related quality of life via Child Health Utility instrument (CHU9D)., 12 months|What are the positive and potential negative effects of a period of LED on the social wellbeing of adolescents., Change in health-related quality of life via the paediatric quality of life inventory - PedsQL 3.2., 12 months|What are the positive and potential negative effects of a period of LED on the social wellbeing of adolescents., Change in health-related quality of life via EQ-5D-Y, a standardised measure adapted for use with young people., 12 months|What are the positive and potential negative effects of a period of LED on the social wellbeing of adolescents., Change in activity via actigraphy., 12 months|What are the positive and potential negative effects of a period of LED on the social wellbeing of adolescents., Change in activity through self-report via Physical Activity Questionnaire (PAQ-A/PAQ-C)., 12 months|What are the positive and potential negative effects of a period of LED on the social wellbeing of adolescents., Acceptability of the intervention from semi-structured interviews conducted with participants and their family/carer, simultaneously., 12 months