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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm Study | Experimental | Total Diet Replacement for 12 weeks, food reintroduction 6 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total Dietary Replacement | Dietary Supplement | Total Dietary Replacement |
|
| Measure | Description | Time Frame |
|---|---|---|
| A change from baseline in HbA1c | mmol/mol | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| A change from baseline in HbA1c | mmol/mol | 1 year |
| A change from baseline in fasting glucose | mmol/l | 12 weeks, 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mandour O Mandour | Contact | 01223768625 | mom30@cam.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| David Savage | Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cambridge University Hospital NHS Foundation Trust | Recruiting | Cambridge | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21656330 | Background | 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. | |
| 29221645 | Background |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 11, 2019 | Nov 23, 2024 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D008060 | Lipodystrophy |
| D003920 | Diabetes Mellitus |
| D052496 | Lipodystrophy, Familial Partial |
| ID | Term |
|---|---|
| D012875 | Skin Diseases, Metabolic |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D052439 | Lipid Metabolism Disorders |
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| A change from baseline in triglycerides | mmol/l | 12 weeks, 1 year |
| A change from baseline in liver fat | % liver fat on MRI | 12 weeks, 1 year |
| A change from baseline in pancreatic fat | % pancreatic fat on MRI | 12 weeks, 1 year |
| A change from baseline in insulin sensitivity | Insulin pmol/l values during oral glucose tolerance test | 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'. | 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 | 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:
The score ranges are: 0 - 4 None 5 - 9 Mild 10 - 14 Moderate 15 - 19 Moderately Severe 20 - 27 Severe | 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. | 12 weeks, 1 year |
| Adult Eating Behaviour Questionnaire | Change in scores in eating behaviour | 12 weeks, 1 year |
| The Three Factor Eating Questionnaire | Change in scores in The Three Factor Eating Questionnaire | 12 weeks, 1 year |
| 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. |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D044882 | Glucose Metabolism Disorders |
| D004700 | Endocrine System Diseases |
| D000083083 | Laminopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008052 | Lipid Metabolism, Inborn Errors |