Clinical trial NCT03900286: Low Energy Diet and Familial Partial Lipodystrophy
Official title: Evaluating the Therapeutic Efficacy and Metabolic Impact of a Low Energy Diet (LED) in People With Familial Partial Lipodystrophy and Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lipodystrophy
Diabetes
Diet Modification
Keywords: Familial Partial Lipodystrophy
FPLD
Diet
Total Diet Replacement
Diabetes
Lead sponsor: Cambridge University Hospitals NHS Foundation Trust
Sponsor class: OTHER
First posted: 2019-04-03
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* History of an eating disorder/ purging behaviour
* Previous gastric bypass/ banding
* Use of Leptin Therapy
* Untreated retinopathy

Primary outcomes:
measure: A change from baseline in HbA1c
timeFrame: 12 weeks
Secondary outcomes:
measure: A change from baseline in HbA1c
timeFrame: 1 year
measure: A change from baseline in fasting glucose
timeFrame: 12 weeks, 1 year
measure: A change from baseline in triglycerides
timeFrame: 12 weeks, 1 year
measure: A change from baseline in liver fat
timeFrame: 12 weeks, 1 year
measure: A change from baseline in pancreatic fat
timeFrame: 12 weeks, 1 year
measure: A change from baseline in insulin sensitivity
timeFrame: 12 weeks, 1 year
measure: A change from baseline in quality of life scores
timeFrame: 12 weeks, 1 year
measure: A change from baseline in anxiety scores
timeFrame: 12 weeks, 1 year
measure: A change from baseline in depression scores
timeFrame: 12 weeks, 1 year
measure: A change from baseline in antidiabetic medication use
timeFrame: 12 weeks, 1 year
measure: Adult Eating Behaviour Questionnaire
timeFrame: 12 weeks, 1 year
measure: The Three Factor Eating Questionnaire
timeFrame: 12 weeks, 1 year
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospital NHS Foundation Trust
Study officials:
affiliation: Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge
name: David Savage
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lim EL, Hollingsworth KG, Aribisala BS, Chen MJ, Mathers JC, Taylor R. Reversal of type 2 diabetes: normalisation of beta cell function in association with decreased pancreas and liver triacylglycerol. Diabetologia. 2011 Oct;54(10):2506-14. doi: 10.1007/s00125-011-2204-7. Epub 2011 Jun 9.
citation: Lean ME, Leslie WS, Barnes AC, Brosnahan N, Thom G, McCombie L, Peters C, Zhyzhneuskaya S, Al-Mrabeh A, Hollingsworth KG, Rodrigues AM, Rehackova L, Adamson AJ, Sniehotta FF, Mathers JC, Ross HM, McIlvenna Y, Stefanetti R, Trenell M, Welsh P, Kean S, Ford I, McConnachie A, Sattar N, Taylor R. Primary care-led weight management for remission of type 2 diabetes (DiRECT): an open-label, cluster-randomised trial. Lancet. 2018 Feb 10;391(10120):541-551. doi: 10.1016/S0140-6736(17)33102-1. Epub 2017 Dec 5.