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NCT Number: NCT03900286

Low Energy Diet and Familial Partial Lipodystrophy

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.

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Key information

Conditions

Lipodystrophy Congenital, Hereditary, and Neonatal Diseases and Abnormalities Diabetes Diabetes Mellitus Diet Modification Endocrine System Diseases Genetic Diseases, Inborn Glucose Metabolism Disorders Laminopathies Lipid Metabolism Disorders Lipid Metabolism, Inborn Errors Lipodystrophy, Familial Partial Metabolic Diseases Nutritional and Metabolic Diseases Skin Diseases Skin Diseases, Metabolic Skin and Connective Tissue Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cambridge University Hospital NHS Foundation Trust

Cambridge, United Kingdom

Location status: Recruiting

Location contact

David Savage

PRINCIPAL_INVESTIGATOR

Mandour O Mandour, MBBS, MRCP

CONTACT

[email protected]

+441233768455

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Total Dietary Replacement

Dietary Supplement

Total Dietary Replacement

Primary outcomes

  1. A change from baseline in HbA1c

    Time frame: 12 weeks

    mmol/mol

Secondary outcomes

  1. A change from baseline in HbA1c

    Time frame: 1 year

    mmol/mol

  2. A change from baseline in fasting glucose

    Time frame: 12 weeks, 1 year

    mmol/l

  3. A change from baseline in triglycerides

    Time frame: 12 weeks, 1 year

    mmol/l

  4. A change from baseline in liver fat

    Time frame: 12 weeks, 1 year

    % liver fat on MRI

  5. A change from baseline in pancreatic fat

    Time frame: 12 weeks, 1 year

    % pancreatic fat on MRI

  6. A change from baseline in insulin sensitivity

    Time frame: 12 weeks, 1 year

    Insulin pmol/l values during oral glucose tolerance test

  7. A change from baseline in quality of life scores

    Time frame: 12 weeks, 1 year

    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'.

  8. A change from baseline in anxiety scores

    Time frame: 12 weeks, 1 year

    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

  9. A change from baseline in depression scores

    Time frame: 12 weeks, 1 year

    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

  10. A change from baseline in antidiabetic medication use

    Time frame: 12 weeks, 1 year

    A change in the amount of antidiabetic drugs taken and/or a change in dose.

  11. Adult Eating Behaviour Questionnaire

    Time frame: 12 weeks, 1 year

    Change in scores in eating behaviour

  12. The Three Factor Eating Questionnaire

    Time frame: 12 weeks, 1 year

    Change in scores in The Three Factor Eating Questionnaire

Study contacts

Contact information is provided by the study sponsor or research team.

Mandour O Mandour

CONTACT

[email protected]

01223768625

Sponsors and collaborators

Lead sponsor

Cambridge University Hospitals NHS Foundation Trust

Other

Registry information

Official study title

Evaluating the Therapeutic Efficacy and Metabolic Impact of a Low Energy Diet (LED) in People With Familial Partial Lipodystrophy and Diabetes

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Apr 3, 2019
Registry last updated
Dec 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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