Clinical Trial

Low Energy Diet and Familial Partial Lipodystrophy

Recruiting
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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.
Summary
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.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2019-04-01; most recent amendment 2024-12-03.
Status change: Not Yet Recruiting → Recruiting 2022-09-05
Trial Details
NCT Number NCT03900286
Lead Sponsor Cambridge University Hospitals NHS Foundation Trust
Conditions Lipodystrophy, Diabetes, Diet Modification
Enrollment 20 participants
Start Date 2020-01-16
Primary Completion 2025-04 (estimated)
Study Completion 2025-05 (estimated)
Updated on ClinicalTrials.gov 2024-12-05