Low Energy Diet and Familial Partial Lipodystrophy

Not Applicable

Recruiting

• Conditions: Lipodystrophy; Diet Modification; Diabetes
• Interventions: Dietary Supplement: Total Dietary Replacement

• Registration Number: NCT03900286
• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-26
• Study First Submitted QC: 2019-04-01
• Study First Posted: 2019-04-03
• Study Start: 2020-01-16
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-05
• Primary Completion: 2025-04
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm Study	Total Dietary Replacement	Total Diet Replacement for 12 weeks, food reintroduction 6 weeks

Primary Outcome Measures

Name	Time	Method
A change from baseline in HbA1c	12 weeks	mmol/mol

Secondary Outcome Measures

Name	Time	Method
A change from baseline in liver fat	12 weeks, 1 year	% liver fat on MRI
A change from baseline in pancreatic fat	12 weeks, 1 year	% pancreatic fat on MRI
A change from baseline in HbA1c	1 year	mmol/mol
A change from baseline in fasting glucose	12 weeks, 1 year	mmol/l
A change from baseline in quality of life scores	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'.
A change from baseline in depression scores	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
The Three Factor Eating Questionnaire	12 weeks, 1 year	Change in scores in The Three Factor Eating Questionnaire
A change from baseline in triglycerides	12 weeks, 1 year	mmol/l
A change from baseline in insulin sensitivity	12 weeks, 1 year	Insulin pmol/l values during oral glucose tolerance test
A change from baseline in antidiabetic medication use	12 weeks, 1 year	A change in the amount of antidiabetic drugs taken and/or a change in dose.
A change from baseline in anxiety scores	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
Adult Eating Behaviour Questionnaire	12 weeks, 1 year	Change in scores in eating behaviour

Trial Locations

Locations (1)

Cambridge University Hospital NHS Foundation Trust; 🇬🇧 Cambridge, United Kingdom