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

Overview

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.

Interventions

• Dietary supplement Total Dietary Replacement
  Total Dietary Replacement

Primary outcome measures

• A change from baseline in HbA1c [Time frame: 12 weeks]

Secondary outcome measures (12)

• A change from baseline in HbA1c [Time frame: 1 year]
• A change from baseline in fasting glucose [Time frame: 12 weeks, 1 year]
• A change from baseline in triglycerides [Time frame: 12 weeks, 1 year]
• A change from baseline in liver fat [Time frame: 12 weeks, 1 year]
• A change from baseline in pancreatic fat [Time frame: 12 weeks, 1 year]
• A change from baseline in insulin sensitivity [Time frame: 12 weeks, 1 year]
• A change from baseline in quality of life scores [Time frame: 12 weeks, 1 year]
• A change from baseline in anxiety scores [Time frame: 12 weeks, 1 year]
• A change from baseline in depression scores [Time frame: 12 weeks, 1 year]
• A change from baseline in antidiabetic medication use [Time frame: 12 weeks, 1 year]
• Adult Eating Behaviour Questionnaire [Time frame: 12 weeks, 1 year]
• The Three Factor Eating Questionnaire [Time frame: 12 weeks, 1 year]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United Kingdom · 1 center

• Cambridge University Hospital NHS Foundation Trust — Cambridge

Publications

• 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. PMID 21656330
• 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-rando PMID 29221645

Identifiers

NCT: NCT03900286 · A095183

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗