About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Familial Partial Lipodystrophy
Age >= 18 yrs
T2DM
Willingness to check daily blood sugars
Disqualifiers
Pregnancy
Untreated thyroid dysfunction (patients who have been euthyroid on medication for at least 3 months can be included)
Use of medication adversely that affects diabetes control (e.g. steroids/ immunosuppressants/ certain antipsychotics)
Incapacity to give informed consent
Trial design
Single group
Treatments tested in this trial
Total Dietary Replacement
Dietary supplementTotal Dietary Replacement
Treatment groups
Trial outcomes
Primary outcomes
A change from baseline in HbA1c
mmol/mol
Secondary outcomes
A change from baseline in HbA1c
mmol/mol
A change from baseline in fasting glucose
mmol/l
A change from baseline in triglycerides
mmol/l
A change from baseline in liver fat
% liver fat on MRI
Sponsors and contacts
Click on the lead sponsor to view all of their trials.