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Search / Trial NCT03900286

Low Energy Diet and Familial Partial Lipodystrophy

Launched by CAMBRIDGE UNIVERSITY HOSPITALS NHS FOUNDATION TRUST · Apr 1, 2019

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Familial Partial Lipodystrophy Fpld Diet Total Diet Replacement Diabetes

ClinConnect Summary

This clinical trial is studying the effects of a low energy diet (LED) on people with familial partial lipodystrophy, a condition that affects how the body stores fat, and diabetes. Participants will follow a strict diet for 12 weeks, during which they will replace their usual meals with specially designed food to help manage their condition. After this initial period, they will gradually reintroduce regular foods. The researchers will monitor participants' health and how well their bodies respond to insulin for a full year. To gain deeper insights into the changes happening in their bodies, some participants may also provide small samples of fat and muscle tissue for analysis.

To be eligible for this trial, participants must be at least 18 years old, have familial partial lipodystrophy, and have type 2 diabetes that is being managed but not completely controlled. They should be stable in weight for the past three months and willing to check their blood sugar levels daily. However, individuals who are pregnant, have untreated thyroid issues, or have a history of eating disorders are not eligible. This study not only aims to improve understanding of how diet can affect insulin sensitivity but also hopes to find effective dietary strategies for managing these complex conditions.

Gender

ALL

Eligibility 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

About Cambridge University Hospitals Nhs Foundation Trust

Cambridge University Hospitals NHS Foundation Trust is a leading healthcare organization in the UK, dedicated to advancing medical research and improving patient care through innovative clinical trials. As a prominent academic health science center, it integrates cutting-edge research with clinical practice, fostering collaboration between healthcare professionals, researchers, and patients. The Trust is committed to delivering high-quality, evidence-based healthcare while actively participating in the development of new therapies and interventions aimed at enhancing health outcomes. With a focus on excellence in clinical research, Cambridge University Hospitals aims to translate scientific discoveries into effective treatments, ultimately benefiting the wider community.

Locations

Cambridge, , United Kingdom

Patients applied

0 patients applied

Trial Officials

David Savage

Principal Investigator

Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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