Evaluating the Therapeutic Efficacy and Metabolic Impact of a Low Energy Diet (LED) in People With Familial Partial Lipodystrophy and Diabetes

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:

• Familial Partial Lipodystrophy

• Age \>= 18 yrs

• T2DM

• Willingness to check daily blood sugars

• HbA1c between 53mmol(7%)- 108 mmol(12%)

• Weight stable for 3 months

• Capacity to consent

Locations
Other Locations
United Kingdom
Cambridge University Hospital NHS Foundation Trust
RECRUITING
Cambridge
Contact Information
Primary
Mandour O Mandour
mom30@cam.ac.uk
01223768625
Time Frame
Start Date: 2020-01-16
Estimated Completion Date: 2025-05
Participants
Target number of participants: 20
Treatments
Experimental: Single Arm Study
Total Diet Replacement for 12 weeks, food reintroduction 6 weeks
Sponsors
Leads: Cambridge University Hospitals NHS Foundation Trust

This content was sourced from clinicaltrials.gov