An interventional study of Total Dietary Replacement in Lipodystrophy, Diabetes and Diet Modification, sponsored by Cambridge University Hospitals NHS Foundation Trust. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-10-27.
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.
20 studies on the registry are indexed under Lipodystrophy, Familial Partial; 5 are open to participants now.
This study's enrollment of 9 is below the median of 16 across 14 interventional studies indexed under Lipodystrophy, Familial Partial.
Browse Lipodystrophy, Familial Partial studies →Cambridge University Hospitals NHS Foundation Trust is the lead sponsor of 171 studies on the registry; 37 are open to participants now.
Compared within Lipodystrophy, Familial Partial, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Lipodystrophy. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Plan to share: No
Ran from Jan 2020 to primary completion in Mar 2026, 73 months.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 27, 2026: primary completion Apr 2025 → Mar 2026 and completion May 2025 → Jul 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Lipodystrophy, Familial Partial →
Cambridge University Hospitals NHS Foundation Trust →