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

NCT06572345 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 73

Last updated 2025-08-03

No results posted yet for this study

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

Low-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.

OTHER

Qualitive interview - LED participants

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

OTHER

Qualitive interview - Participants declining LED

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

OTHER

Qualitive interview - Health Care Professionals (HCPs)

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

Sponsors & Collaborators

  • Diabetes UK

    collaborator OTHER

  • Nottingham University Hospitals NHS Trust

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-30
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06572345 on ClinicalTrials.gov