Low Energy Diet and Familial Partial Lipodystrophy

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.

Full Title of Study: “Evaluating the Therapeutic Efficacy and Metabolic Impact of a Low Energy Diet (LED) in People With Familial Partial Lipodystrophy and Diabetes”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 2021

Interventions

  • Dietary Supplement: Total Dietary Replacement
    • Total Dietary Replacement

Arms, Groups and Cohorts

  • Experimental: Single Arm Study
    • Total Diet Replacement for 12 weeks, food reintroduction 6 weeks

Clinical Trial Outcome Measures

Primary Measures

  • A change from baseline in HbA1c
    • Time Frame: 12 weeks
    • mmol/mol

Secondary Measures

  • A change from baseline in HbA1c
    • Time Frame: 1 year
    • mmol/mol
  • A change from baseline in fasting glucose
    • Time Frame: 12 weeks, 1 year
    • mmol/l
  • A change from baseline in triglycerides
    • Time Frame: 12 weeks, 1 year
    • mmol/l
  • A change from baseline in liver fat
    • Time Frame: 12 weeks, 1 year
    • % liver fat on MRI
  • A change from baseline in pancreatic fat
    • Time Frame: 12 weeks, 1 year
    • % pancreatic fat on MRI
  • A change from baseline in insulin sensitivity
    • Time Frame: 12 weeks, 1 year
    • Insulin pmol/l values during oral glucose tolerance test
  • A change from baseline in quality of life scores
    • Time Frame: 12 weeks, 1 year
    • Change in scores of EQ-5D-3L Quality of Life measurement from baseline. EQ-5D-3L is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life. It comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results into a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient’s health state. The EQ VAS records the patient’s self-rated health on a vertical visual analogue scale where the endpoints are labelled ‘Best imaginable health state’ and ‘Worst imaginable health state’.
  • A change from baseline in anxiety scores
    • Time Frame: 12 weeks, 1 year
    • Change in scores of Generalised Anxiety Disorder-7 (GAD 7) from baseline. Change in scores of Generalised Anxiety Disorder-7 (GAD 7) from baseline. The Generalised Anxiety Disorder-7 (GAD 7) Questionnaire is a 7 item measurement that is used to measure or assess the severity of generalised anxiety disorder (GAD) The index scores are as follows: 0 – 4 No Anxiety 5 – 10 Mild Anxiety 11 – 15 Moderate Anxiety 15 – 21 Severe Anxiety
  • A change from baseline in depression scores
    • Time Frame: 12 weeks, 1 year
    • Change in scores of Patient Health Questionnaire-9 (PHQ9), from baseline. The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. The responses for each of the 9 items are: 0 – Not at all 1 – Several days 2 – More than half the day 3 – Nearly every day The score ranges are: 0 – 4 None 5 – 9 Mild 10 – 14 Moderate 15 – 19 Moderately Severe 20 – 27 Severe
  • A change from baseline in antidiabetic medication use
    • Time Frame: 12 weeks, 1 year
    • A change in the amount of antidiabetic drugs taken and/or a change in dose.
  • Adult Eating Behaviour Questionnaire
    • Time Frame: 12 weeks, 1 year
    • Change in scores in eating behaviour
  • The Three Factor Eating Questionnaire
    • Time Frame: 12 weeks, 1 year
    • Change in scores in The Three Factor Eating Questionnaire

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 99 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Cambridge University Hospitals NHS Foundation Trust
  • Provider of Information About this Clinical Study
    • Principal Investigator: Professor David Savage, Wellcome Trust Senior Clinical Fellow – Cambridge University Hospitals NHS Foundation Trust
  • Overall Official(s)
    • David Savage, Principal Investigator, Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge
  • Overall Contact(s)
    • Claire Adams, 0044(0)1233768625, ca337@medschl.cam.ac.uk

References

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.

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.

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