Actively Recruiting
Low Energy Diet and Familial Partial Lipodystrophy
Led by Cambridge University Hospitals NHS Foundation Trust · Updated on 2024-12-05
20
Participants Needed
1
Research Sites
276 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Low Energy Diet and Familial Partial Lipodystrophy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with familial partial lipodystrophy
- Age 18 years or older
- Diagnosed with type 2 diabetes mellitus (T2DM)
- Willing to check blood sugar levels daily
- HbA1c between 53 mmol/mol (7%) and 108 mmol/mol (12%)
- Weight stable for at least 3 months
- Able to give informed consent
You will not qualify if you...
- Currently pregnant
- Untreated thyroid dysfunction (except if stable on medication for at least 3 months)
- Use of medications that worsen diabetes control (such as steroids, immunosuppressants, certain antipsychotics)
- Unable to give informed consent
- History of eating disorders or purging behavior
- Previous gastric bypass or banding surgery
- Currently using leptin therapy
- Untreated diabetic retinopathy
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Cambridge University Hospital NHS Foundation Trust
Cambridge, United Kingdom
Actively Recruiting
Research Team
M
Mandour O Mandour
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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