NCT03900286

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 3, 2019

Completed
10 months until next milestone

Study Start

First participant enrolled

January 16, 2020

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

December 5, 2024

Status Verified

December 1, 2024

Enrollment Period

5.2 years

First QC Date

March 26, 2019

Last Update Submit

December 3, 2024

Conditions

LipodystrophyDiabetesDiet Modification

Keywords

Familial Partial LipodystrophyFPLDDietTotal Diet ReplacementDiabetes

Outcome Measures

Primary Outcomes (1)

  • A change from baseline in HbA1c

    mmol/mol

    12 weeks

Secondary Outcomes (12)

  • A change from baseline in HbA1c

    1 year

  • A change from baseline in fasting glucose

    12 weeks, 1 year

  • A change from baseline in triglycerides

    12 weeks, 1 year

  • A change from baseline in liver fat

    12 weeks, 1 year

  • A change from baseline in pancreatic fat

    12 weeks, 1 year

  • +7 more secondary outcomes

Study Arms (1)

Single Arm Study

EXPERIMENTAL

Total Diet Replacement for 12 weeks, food reintroduction 6 weeks

Dietary Supplement: Total Dietary Replacement

Interventions

Total Dietary ReplacementDIETARY_SUPPLEMENT

Total Dietary Replacement

Single Arm Study

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cambridge University Hospital NHS Foundation Trust

Cambridge, United Kingdom

RECRUITING

Related Publications (2)

  • 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.

    PMID: 21656330BACKGROUND

  • 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.

    PMID: 29221645BACKGROUND

MeSH Terms

Conditions

LipodystrophyDiabetes MellitusLipodystrophy, Familial Partial

Condition Hierarchy (Ancestors)

Skin Diseases, MetabolicSkin DiseasesSkin and Connective Tissue DiseasesLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism DisordersEndocrine System DiseasesLaminopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesLipid Metabolism, Inborn Errors

Study Officials

  • David Savage

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mandour O Mandour

CONTACT

01223768625mom30@cam.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Wellcome Trust Senior Clinical Fellow

Study Record Dates

First Submitted

March 26, 2019

First Posted

April 3, 2019

Study Start

January 16, 2020

Primary Completion

April 1, 2025

Study Completion

May 1, 2025

Last Updated

December 5, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)