LipodystrophyNCT03900286
Low Energy Diet and Familial Partial Lipodystrophy
A study testing Total Dietary Replacement in people with Lipodystrophy and Diabetes, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Lipodystrophy, Diabetes, Diet Modification
- What is being tested?
- Total Dietary Replacement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Jan 2020to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Cambridge University Hospital NHS Foundation Trust
Cambridge
About this study
Official title: Evaluating the Therapeutic Efficacy and Metabolic Impact of a Low Energy Diet (LED) in People With Familial Partial Lipodystrophy and Diabetes
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.
- Conditions
- Lipodystrophy, Diabetes, Diet Modification
- Being tested
- Total Dietary Replacement
- Keywords
- Familial Partial Lipodystrophy, FPLD, Diet, Total Diet Replacement, Diabetes
- Medical subject headings
- Lipodystrophy, Diabetes Mellitus, Lipodystrophy, Familial Partial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Dietary ReplacementDietary supplement
Total Dietary Replacement
| Study group | Role | What they receive |
|---|---|---|
| Single Arm Study | Experimental | Total Diet Replacement for 12 weeks, food reintroduction 6 weeks Receives: Dietary Supplement: Total Dietary Replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
A change from baseline in HbA1c
mmol/mol
Measured: 12 weeks
Secondary outcomes (12)
A change from baseline in HbA1c
mmol/mol
Measured: 1 year
A change from baseline in fasting glucose
mmol/l
Measured: 12 weeks, 1 year
A change from baseline in triglycerides
mmol/l
Measured: 12 weeks, 1 year
A change from baseline in liver fat
% liver fat on MRI
Measured: 12 weeks, 1 year
A change from baseline in pancreatic fat
% pancreatic fat on MRI
Measured: 12 weeks, 1 year
A change from baseline in insulin sensitivity
Insulin pmol/l values during oral glucose tolerance test
Measured: 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'.
Measured: 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
Measured: 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
Measured: 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.
Measured: 12 weeks, 1 year
Adult Eating Behaviour Questionnaire
Change in scores in eating behaviour
Measured: 12 weeks, 1 year
The Three Factor Eating Questionnaire
Change in scores in The Three Factor Eating Questionnaire
Measured: 12 weeks, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2019
- Study start16 Jan 2020
- Primary completion1 Mar 2026
- Study completion1 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for LipodystrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cambridge University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mandour Omer Mandour, Cambridge University Hospitals NHS Foundation Trust
- Investigators
- David Savage, Principal investigator, Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03900286
- Sponsor's protocol ID
- A095183
- Status last verified
- Oct 2026
- First submitted
- 26 Mar 2019
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21656330Lean 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.
PubMed 29221645
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Therapeutic Efficacy and Metabolic Impact of a Low Energy Diet (LED) in People With Familial Partial Lipodystrophy and Diabetes
- ClinicalTrials.gov ID
- NCT03900286
- Acronym / sponsor ID
- A095183
- Conditions
- Lipodystrophy, Diabetes, Diet Modification
- Keywords
- Familial Partial Lipodystrophy, FPLD, Diet, Total Diet Replacement, Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Cambridge University Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- 16 Jan 2020 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 1 Jul 2026 (actual)
- First posted
- 3 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm Study | Experimental | Dietary Supplement: Total Dietary ReplacementTotal Diet Replacement for 12 weeks, food reintroduction 6 weeks |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Familial Partial Lipodystrophy
- Age >= 18 yrs
- T2DM
- Willingness to check daily blood sugars
- HbA1c between 53mmol(7%)- 108 mmol(12%)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total Dietary ReplacementTotal Dietary Replacement | Dietary supplement | Single Arm Study |
Primary outcome
A change from baseline in HbA1c
Time frame: 12 weeks
mmol/mol
12 secondary outcomes
A change from baseline in HbA1c
Time frame: 1 year
A change from baseline in fasting glucose
Time frame: 12 weeks, 1 year
A change from baseline in triglycerides
Time frame: 12 weeks, 1 year
A change from baseline in liver fat
Time frame: 12 weeks, 1 year
A change from baseline in pancreatic fat
Time frame: 12 weeks, 1 year
A change from baseline in insulin sensitivity
Time frame: 12 weeks, 1 year
A change from baseline in quality of life scores
Time frame: 12 weeks, 1 year
A change from baseline in anxiety scores
Time frame: 12 weeks, 1 year
A change from baseline in depression scores
Time frame: 12 weeks, 1 year
A change from baseline in antidiabetic medication use
Time frame: 12 weeks, 1 year
Adult Eating Behaviour Questionnaire
Time frame: 12 weeks, 1 year
The Three Factor Eating Questionnaire
Time frame: 12 weeks, 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Background: PubMed 21656330Lim 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.
- Background: PubMed 29221645Lean 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Savage principal investigator
Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total Dietary Replacement in people with Lipodystrophy and Diabetes, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A change from baseline in HbA1c (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03900286, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.