RecruitingNot ApplicableNCT06572345

Low EnerGy DiEt iN Adolescents With Obesity and Type 2 Diabetes: The LEGEND Study

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

Sponsor

Nottingham University Hospitals NHS Trust

Enrollment

73 participants

Start Date

Jun 30, 2025

Study Type

INTERVENTIONAL

Conditions

Type 2 Diabetes Pediatric Obesity

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.

Eligibility

Min Age: 12 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This study (called LEGEND) is testing whether a very low-calorie diet can help teenagers with obesity and type 2 diabetes improve their blood sugar levels — potentially putting the diabetes into remission. **You may be eligible if...** - You are 12 to 17 years old - You have been diagnosed with type 2 diabetes (HbA1c of 48 mmol/mol or above) - Your BMI is above the 98th percentile for your age and sex (considered obese) - You or a parent/carer can give informed consent - You are willing to commit to the diet program and follow-up visits **You may NOT be eligible if...** - You have type 1 diabetes, monogenic diabetes, or other causes of high blood sugar - Your HbA1c is above 80 mmol/mol (very high and hard to manage with diet alone) - You are unable to follow the program or attend visits Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTLow-energy diet

For the first 12 weeks during the LED, participants will have 4 meal replacement products each day. The following 12 weeks consists of a gradual reintroduction of food one meal at a time, in a structured stepwise progression, under the supervision of a dietitian. They will then undergo 28 weeks of weight maintenance to see if they are able to keep their weight stable.

OTHERQualitive interview - LED participants

Semi-structured interviews with 10 of the LED participants and their relative/carer.

OTHERQualitive interview - Participants declining LED

Semi-structured interviews with 10 participants who declined the LED, and their relative/carer.

OTHERQualitive interview - Health Care Professionals (HCPs)

Semi-structured interviews with 10 HCPs involved in delivery of the trial.

Locations(1)

Nottingham University Hospital NHS Trust

Nottingham, United Kingdom

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