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Low Energy Diet and Familial Partial Lipodystrophy

Primary Purpose

Lipodystrophy, Diabetes, Diet Modification

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Total Dietary Replacement
Sponsored by
Cambridge University Hospitals NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lipodystrophy focused on measuring Familial Partial Lipodystrophy, FPLD, Diet, Total Diet Replacement, Diabetes

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cambridge University Hospital NHS Foundation TrustRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single Arm Study

Arm Description

Total Diet Replacement for 12 weeks, food reintroduction 6 weeks

Outcomes

Primary Outcome Measures

A change from baseline in HbA1c
mmol/mol

Secondary Outcome Measures

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

Full Information

First Posted
March 26, 2019
Last Updated
May 25, 2023
Sponsor
Cambridge University Hospitals NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT03900286
Brief Title
Low Energy Diet and Familial Partial Lipodystrophy
Official Title
Evaluating the Therapeutic Efficacy and Metabolic Impact of a Low Energy Diet (LED) in People With Familial Partial Lipodystrophy and Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 16, 2020 (Actual)
Primary Completion Date
April 2025 (Anticipated)
Study Completion Date
May 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cambridge University Hospitals NHS Foundation Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lipodystrophy, Diabetes, Diet Modification
Keywords
Familial Partial Lipodystrophy, FPLD, Diet, Total Diet Replacement, Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single Arm Study
Arm Type
Experimental
Arm Description
Total Diet Replacement for 12 weeks, food reintroduction 6 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Total Dietary Replacement
Intervention Description
Total Dietary Replacement
Primary Outcome Measure Information:
Title
A change from baseline in HbA1c
Description
mmol/mol
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
A change from baseline in HbA1c
Description
mmol/mol
Time Frame
1 year
Title
A change from baseline in fasting glucose
Description
mmol/l
Time Frame
12 weeks, 1 year
Title
A change from baseline in triglycerides
Description
mmol/l
Time Frame
12 weeks, 1 year
Title
A change from baseline in liver fat
Description
% liver fat on MRI
Time Frame
12 weeks, 1 year
Title
A change from baseline in pancreatic fat
Description
% pancreatic fat on MRI
Time Frame
12 weeks, 1 year
Title
A change from baseline in insulin sensitivity
Description
Insulin pmol/l values during oral glucose tolerance test
Time Frame
12 weeks, 1 year
Title
A change from baseline in quality of life scores
Description
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'.
Time Frame
12 weeks, 1 year
Title
A change from baseline in anxiety scores
Description
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
Time Frame
12 weeks, 1 year
Title
A change from baseline in depression scores
Description
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
Time Frame
12 weeks, 1 year
Title
A change from baseline in antidiabetic medication use
Description
A change in the amount of antidiabetic drugs taken and/or a change in dose.
Time Frame
12 weeks, 1 year
Title
Adult Eating Behaviour Questionnaire
Description
Change in scores in eating behaviour
Time Frame
12 weeks, 1 year
Title
The Three Factor Eating Questionnaire
Description
Change in scores in The Three Factor Eating Questionnaire
Time Frame
12 weeks, 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Catarina Lopes
Phone
01223768625
Email
cl765@medschl.cam.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Savage
Organizational Affiliation
Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cambridge University Hospital NHS Foundation Trust
City
Cambridge
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catarina Lopes
Phone
+441233768455
Email
cl765@medschl.cam.ac.uk
First Name & Middle Initial & Last Name & Degree
David Savage

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21656330
Citation
Lim EL, Hollingsworth KG, Aribisala BS, Chen MJ, Mathers JC, Taylor R. Reversal of type 2 diabetes: normalisation of beta cell function in association with decreased pancreas and liver triacylglycerol. Diabetologia. 2011 Oct;54(10):2506-14. doi: 10.1007/s00125-011-2204-7. Epub 2011 Jun 9.
Results Reference
background
PubMed Identifier
29221645
Citation
Lean ME, Leslie WS, Barnes AC, Brosnahan N, Thom G, McCombie L, Peters C, Zhyzhneuskaya S, Al-Mrabeh A, Hollingsworth KG, Rodrigues AM, Rehackova L, Adamson AJ, Sniehotta FF, Mathers JC, Ross HM, McIlvenna Y, Stefanetti R, Trenell M, Welsh P, Kean S, Ford I, McConnachie A, Sattar N, Taylor R. Primary care-led weight management for remission of type 2 diabetes (DiRECT): an open-label, cluster-randomised trial. Lancet. 2018 Feb 10;391(10120):541-551. doi: 10.1016/S0140-6736(17)33102-1. Epub 2017 Dec 5.
Results Reference
background

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Low Energy Diet and Familial Partial Lipodystrophy

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