Low Energy Diet and Familial Partial Lipodystrophy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorCambridge University Hospitals NHS Foundation Trust

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Total Dietary Replacement

    Dietary supplement

    Total Dietary Replacement

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Single Arm StudyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

A change from baseline in HbA1c

mmol/mol

Time frame
12 weeks

Secondary outcomes

1

A change from baseline in HbA1c

mmol/mol

Time frame
1 year
2

A change from baseline in fasting glucose

mmol/l

Time frame
12 weeks, 1 year
3

A change from baseline in triglycerides

mmol/l

Time frame
12 weeks, 1 year
4

A change from baseline in liver fat

% liver fat on MRI

Time frame
12 weeks, 1 year

Other outcomes

Sponsors and contacts

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