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Low Energy Diet and Familial Partial Lipodystrophy

StatusRecruiting
PhaseNot applicable
Started
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Record status
This record was last updated December 5, 2024 (before its estimated April 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Site contact updatedv6
  2. Primary completion date: Apr 2023 to Apr 2025
    • Study completion date: May 2023 to May 2025
    • Site contact updated
    v5
  3. Trial status: Not Yet Recruiting to Recruitingv4 Show 4 more changesShow less
    • Primary completion date: Apr 2021 to Apr 2023
    • Start date changed from estimate of Jul 16, 2019 to Jan 16, 2020
    • Study sites: 0 to 1
    • Study completion date: May 2021 to May 2023
  4. Start date: May 2019 to Jul 16, 2019
    • Secondary endpoints: 10 to 12
    v3
  5. Secondary endpoints: details revised at 3 of 10 entriesv2
  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
To evaluate the therapeutic efficacy and metabolic impact of a low energy diet (LED) in people with familial partial lipodystrophy and diabetes. Participants will be provided with a LED (total diet replacement) for 12 weeks, before the introduction of a stepped food transition. Metabolic effects will continue to be assessed for 1 year. In order to better understand why this intervention changes insulin sensitivity, we will also collect adipose and muscle tissue samples at baseline and 12 weeks into the intervention in participants willing to have these procedures performed. These samples will be used for histological, metabolite, gene expression and protein expression analyses.
Trial Details
NCT Number NCT03900286
Lead Sponsor Cambridge University Hospitals NHS Foundation Trust
Conditions
(from sponsor)		 Lipodystrophy, Diabetes, Diet Modification
Related terms Diabetes Mellitus, Lipodystrophy, Lipodystrophy, Familial Partial
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov