Low Energy Diet and Familial Partial Lipodystrophy

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03900286
• Other study ID #: A095183
• Status: Recruiting
• Phase: N/A
• Start date: January 16, 2020
• Est. completion date: May 2025

Study information

• Verified date: May 2023
• Source: Cambridge University Hospitals NHS Foundation Trust
• Contact: Catarina Lopes
• Phone: 01223768625
• Email: cl765[@]medschl.cam.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: May 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diet Modification
• Lipodystrophy
• Lipodystrophy, Familial Partial

Intervention

Dietary Supplement:
• Total Dietary Replacement
Total Dietary Replacement

Locations

Country	Name	City	State
United Kingdom	Cambridge University Hospital NHS Foundation Trust	Cambridge

Sponsors (1)

Lead Sponsor	Collaborator
Cambridge University Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A change from baseline in HbA1c	mmol/mol	12 weeks
Secondary	A change from baseline in HbA1c	mmol/mol	1 year
Secondary	A change from baseline in fasting glucose	mmol/l	12 weeks, 1 year
Secondary	A change from baseline in triglycerides	mmol/l	12 weeks, 1 year
Secondary	A change from baseline in liver fat	% liver fat on MRI	12 weeks, 1 year
Secondary	A change from baseline in pancreatic fat	% pancreatic fat on MRI	12 weeks, 1 year
Secondary	A change from baseline in insulin sensitivity	Insulin pmol/l values during oral glucose tolerance test	12 weeks, 1 year
Secondary	A change from baseline in quality of life scores	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'.	12 weeks, 1 year
Secondary	A change from baseline in anxiety scores	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	12 weeks, 1 year
Secondary	A change from baseline in depression scores	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	12 weeks, 1 year
Secondary	A change from baseline in antidiabetic medication use	A change in the amount of antidiabetic drugs taken and/or a change in dose.	12 weeks, 1 year
Secondary	Adult Eating Behaviour Questionnaire	Change in scores in eating behaviour	12 weeks, 1 year
Secondary	The Three Factor Eating Questionnaire	Change in scores in The Three Factor Eating Questionnaire	12 weeks, 1 year