An interventional study of Total Dietary Replacement in Lipodystrophy, Diabetes and Diet Modification, sponsored by Cambridge University Hospitals NHS Foundation Trust. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2024-12-05.
Sponsored by Cambridge University Hospitals NHS Foundation Trust · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
Total Diet Replacement for 12 weeks, food reintroduction 6 weeks
Dietary Supplement: Total Dietary Replacement
Total Dietary Replacement
A change from baseline in HbA1c
mmol/mol
Time frame: 12 weeks
A change from baseline in HbA1c
mmol/mol
Time frame: 1 year
A change from baseline in fasting glucose
mmol/l
Time frame: 12 weeks, 1 year
A change from baseline in triglycerides
mmol/l
Time frame: 12 weeks, 1 year
A change from baseline in liver fat
% liver fat on MRI
Time frame: 12 weeks, 1 year
A change from baseline in pancreatic fat
% pancreatic fat on MRI
Time frame: 12 weeks, 1 year
A change from baseline in insulin sensitivity
Insulin pmol/l values during oral glucose tolerance test
Time frame: 12 weeks, 1 year
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'.
Time frame: 12 weeks, 1 year
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
Time frame: 12 weeks, 1 year
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
Time frame: 12 weeks, 1 year
A change from baseline in antidiabetic medication use
A change in the amount of antidiabetic drugs taken and/or a change in dose.
Time frame: 12 weeks, 1 year
Adult Eating Behaviour Questionnaire
Change in scores in eating behaviour
Time frame: 12 weeks, 1 year
The Three Factor Eating Questionnaire
Change in scores in The Three Factor Eating Questionnaire
Time frame: 12 weeks, 1 year
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Plan to share: No
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Lipodystrophy, Familial Partial→
Cambridge University Hospitals NHS Foundation Trust