Low energy diet for managing familial partial lipodystrophy and diabetes
Evaluating the Therapeutic Efficacy and Metabolic Impact of a Low Energy Diet (LED) in People With Familial Partial Lipodystrophy and Diabetes
This study is testing whether a low energy diet can help people with familial partial lipodystrophy and diabetes improve their insulin sensitivity and overall health over 12 weeks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Cambridge University Hospitals NHS Foundation Trust Academic / other |
| Locations | 1 site (Cambridge) |
| Trial ID | NCT03900286 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a low energy diet (LED) as a total diet replacement for individuals with familial partial lipodystrophy and diabetes over a 12-week period. Participants will undergo metabolic assessments and provide adipose and muscle tissue samples to understand the intervention's impact on insulin sensitivity. Following the LED phase, a gradual food transition will be introduced, and metabolic effects will be monitored for one year. The study aims to gather insights into the metabolic changes associated with this dietary intervention.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with familial partial lipodystrophy and type 2 diabetes who are stable in weight and willing to monitor their blood sugar levels.
Not a fit: Patients who are pregnant, have untreated thyroid dysfunction, or a history of eating disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve metabolic health and insulin sensitivity in patients with familial partial lipodystrophy and diabetes.
How similar studies have performed: Other studies have shown promising results with dietary interventions in metabolic disorders, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where this trial is running
Cambridge
- Cambridge University Hospital NHS Foundation Trust — Cambridge, United Kingdom (Recruiting)
Study contacts
- Principal investigator: David Savage — Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge
- Study coordinator: Mandour O Mandour
- Email: mom30@cam.ac.uk
- Phone: 01223768625
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.