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

Study acronym: LEGEND
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Primary and study completion dates: Dec 31, 2026 to May 29, 2028
    • Eligibility criteria expanded, about 49 words
    v7
  2. Trial status: Active, Not Recruiting to Recruiting
    • Site details revised
    v6
  3. Secondary endpoints: 46 to 44v5
  4. Trial status: Not Yet Recruiting to Active, Not Recruiting
    • Start date changed from estimate of Jun 2025 to Jun 30, 2025
    • Site contact updated
    v4
  5. Start date: Mar 2025 to Jun 2025
    • Site contact updated
    v3
  6. Start date: Sep 1, 2024 to Mar 2025
    • Secondary endpoints revised (46)
    • Site contact updated
    v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06572345
Lead Sponsor Nottingham University Hospitals NHS Trust
Collaborators: Diabetes UK
Conditions
(from sponsor)		 Pediatric Obesity, Type 2 Diabetes
Related terms Diabetes Mellitus, Type 2, Obesity, Pediatric Obesity
Enrollment 73 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov