At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Total Dietary Replacement (supplement)
- How long the study runs
- Study runs about 64 months (dates as stated)
- About the drug or intervention
- Total Dietary Replacement — supplement: Total Dietary Replacement
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years to 99 Years
- Who
- All
- Number of participants
- 20
- Started
- 2020-01-16
- Last checked
- 2024-12
Plain English Summary
What is this study?
- • Testing a new treatment for lipodystrophy
- • NA - 20 participants
- • To evaluate the therapeutic efficacy and metabolic impact of a low energy diet (LED) in people with familial partial lipodystrophy and diabetes
Who can take part?
- • Ages 18 Years to 99 Years
- • Diagnosed with lipodystrophy
Where?
- • Cambridge - Cambridge University Hospital NHS Foundation Trust
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 99 Years
- Who can join: All genders
What the study is looking for
- ✓Familial Partial Lipodystrophy
- ✓Age \>= 18 yrs
- ✓Willingness to check daily blood sugars
- ✓HbA1c between 53mmol(7%)- 108 mmol(12%)
- ✓Weight stable for 3 months
Who cannot take part
- ✗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 agreement to take part
- ✗History of an eating disorder/ purging behaviour
See the full criteria
Where Is This Study? (1 UK site)
Cambridge University Hospital NHS Foundation Trust
Cambridge, United Kingdom
How to Get in Touch
Mandour O Mandour
Sponsor contactCONTACT