Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

Regulation of Lipid Metabolism in Autoimmune Disease: Multiple Sclerosis (RELOAD-MS)

22 april 2020 uppdaterad av: University College, London
The aim of this research is to understand how lipids such as cholesterol affect the disease process in people with MS.

Studieöversikt

Status

Okänd

Betingelser

Intervention / Behandling

Detaljerad beskrivning

In Multiple Sclerosis (MS) immune cells recognise myelin, the coating around nerve fibres, as a foreign molecule and attack it by mistake; at the same time regulatory immune cells (which are normally protective) do not work properly and cannot block the harmful effects of the activated immune cells effectively.

Immune cells work via a complex system of signals that start on the outside layer of the cell (the plasma membrane), these signals are transmitted inside the cell where they trigger immune cell activation. The plasma membrane consists of a fatty layer and changes in the type of fat in the membrane can affect immune cell signalling and immune cell function.

The aims of this project are to:

  1. Identify what is different about the types of fat in immune cells from healthy donors and people with MS and identify what triggers the production of these different types of fat.
  2. Identify how different types of fat control immune cell function in healthy donors and people with MS
  3. Identify possible ways to regulate the type of fat in immune cell membranes to restore normal immune cell function in MS.

Methods: This research study involves collecting participant demographic and clinical information, blood and Cerebral Spinal Fluid (CSF) (optional) from patients with MS. Blood will also be collected from healthy volunteers for comparison. Experiments will be performed on the blood samples and the results correlated with the clinical and disease features of patients.

Outcomes: Many of the molecules involved in the generation of fats are well known and for some of them drugs are already used in humans to treat diseases (for example statins). This could allow the rapid translation of the results from this study to the clinic and have a direct impact for people with MS.

Studietyp

Observationell

Inskrivning (Förväntat)

275

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Studieorter

  • Storbritannien
      • London, Storbritannien, NW1 2BU
        • Rekrytering
        • University College London Hospitals Nhs Foundation Trust
        • Kontakt:
      • London, Storbritannien, WC1N 3BG
        • Rekrytering
        • National Hospital For Neurology and Neurosurgery
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 80 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

Those with and those without MS

Beskrivning

Inclusion Criteria:

  • 01. Male and female patients of between 18 years and 80 years of age with a diagnosis of MS or CIS.
  • Diagnosis confirmed according to the standards at the time when diagnosis was made.
  • Patients not receiving biological DMDs within the previous 3 months OR
  • Patients treated with DMDs (Interferon beta (Rebif, Betaferon, Avonex, Plegridy), Glatiramer Acetate (Copaxone), Dimethylfumarate (Tecfidera), Fingolimod (Gilenya), Teriflunomide (Aubagio), Natalizumab (Tysabri),) Alemtuzumab (Lemtrada), immunosuppressive drugs (azathioprine, cyclophosphamide etc) who have stable disease in the last 3 months.
  • Last course of corticosteroids more than three months ago.
  • 02. Having given written informed consent prior to undertaking any study-related procedures.
  • 03. Covered by a health insurance system where applicable, and/or in compliance with the recommendations of the national laws in force relating to biomedical research.
  • 04. Healthy donors ONLY : Male and female donors of between 18 years and 80 years of age in good health and not aware of any diagnosis of an autoimmune condition.

Exclusion Criteria:

  • 01. Patients currently taking statins or other lipid lowering therapies.
  • 02. Under any administrative or legal supervision.
  • 03. Conditions/situations such as:
  • Patients with conditions/concomitant diseases making them non evaluable for the primary endpoint
  • Impossibility to meet specific protocol requirements (e.g. blood sampling)
  • Patient is the Investigator or any sub investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol
  • Uncooperative or any condition that could make the patient potentially non-compliant to the study procedures
  • Pregnant or breast-feeding women, currently or in the last three months prior to inclusion
  • Patients who have been vaccinated in the last three months prior to inclusion

Healthy donors ONLY: will be excluded from the study if:

  • Donors with a condition likely to influence your blood results such as a current infection or cancer
  • Donors who are pregnant or breast-feeding currently or in the last three months
  • Donors who have been vaccinated within the last three months
  • Donors who cannot provide a blood sample
  • Donors who are unable to give informed consent

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
DMD treatment naive CIS or RRMS patients
Newly presenting Clinically Isolated Syndrome (CIS) or Relapsing and Remitting Multiple Sclerosis (RRMS) patients not treated before with Disease Modifying Drugs (DMD) Additional analysis of CSF and CSF cells will be performed in this cohort on a voluntary basis.
Övrig: Blood sampling
Blood sampling +/- CSF sampling
Andra namn:
  • CSF sampling
Secondary Progressive Multiple Sclerosis (SPMS)
People with confirmed diagnosis of SPMS
Övrig: Blood sampling
Blood sampling +/- CSF sampling
Andra namn:
  • CSF sampling
Primary Progressive Multiple Sclerosis (PPMS)
People with confirmed diagnosis of PPMS
Övrig: Blood sampling
Blood sampling +/- CSF sampling
Andra namn:
  • CSF sampling
DMD-treated with stable disease
People with Multiple Sclerosis (MS) who are treated with DMD who have had stable disease symptoms for at least 3 months
Övrig: Blood sampling
Blood sampling +/- CSF sampling
Andra namn:
  • CSF sampling
Disease controls
People who undergo lumbar puncture due to clinical suspicion of neurological condition, but brain Magnetic Resonance Imaging (MRI) and CSF examination exclude MS diagnosis.
Övrig: Blood sampling
Blood sampling +/- CSF sampling
Andra namn:
  • CSF sampling
Healthy donors
Age, sex and ethnicity matched healthy donors will also be recruited from university and hospital staff and patient friends after informed consent has been obtained. Healthy donors will be asked to provide a blood sample and demographic information but will NOT be asked to provide CSF samples.
Övrig: Blood sampling
Blood sampling +/- CSF sampling
Andra namn:
  • CSF sampling

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Lipid Phenotyping (1)
Tidsram: 4 hours from point of sample collection
Blood samples collected from consented participants containing the peripheral blood mononuclear cells (PBMC), serum, Deoxyribonucleic Acid (DNA) and CSF/CSF cells will be appropriately sent to Dr Elizabeth Jury, Centre for Rheumatology Research, University College London (UCL), Rayne Building for lipid phenotyping of PBMC using flow cytometry
4 hours from point of sample collection
Lipid Phenotyping (2)
Tidsram: 4 hours from point of sample collection
Blood samples collected from consented participants containing the peripheral blood mononuclear cells (PBMC), serum, Deoxyribonucleic Acid (DNA) and CSF/CSF cells will be appropriately sent to Dr Elizabeth Jury, Centre for Rheumatology Research, University College London, Rayne Building for lipid phenotyping of PBMC using measurement of quantitative polymerase chain reaction (qPCR)
4 hours from point of sample collection
Analysis of immune cell function
Tidsram: 4 hours from point of sample collection
Blood samples collected from consented participants containing the peripheral blood mononuclear cells (PBMC), serum, Deoxyribonucleic Acid (DNA) and CSF/CSF cells will be appropriately sent to Dr Elizabeth Jury, Centre for Rheumatology Research, University College London, Rayne Building for analysis of immune cell function using flow cytometry.
4 hours from point of sample collection
Analysis of cytokine
Tidsram: 4 hours from point of sample collection
Blood samples collected from consented participants containing the peripheral blood mononuclear cells (PBMC), serum, Deoxyribonucleic Acid (DNA) and CSF/CSF cells will be appropriately sent to Dr Elizabeth Jury, Centre for Rheumatology Research, University College London, Rayne Building for analysis of cytokine using flow cytometry.
4 hours from point of sample collection
Analysis of immune cell function (1)
Tidsram: 4 hours from point of sample collection
Blood samples collected from consented participants containing the peripheral blood mononuclear cells (PBMC), serum, Deoxyribonucleic Acid (DNA) and CSF/CSF cells will be appropriately sent to Dr Elizabeth Jury, Centre for Rheumatology Research, University College London, Rayne Building for analysis of immune cell function through cell culture.
4 hours from point of sample collection
Analysis of immune cell function (2)
Tidsram: 4 hours from point of sample collection
Blood samples collected from consented participants containing the peripheral blood mononuclear cells (PBMC), serum, Deoxyribonucleic Acid (DNA) and CSF/CSF cells will be appropriately sent to Dr Elizabeth Jury, Centre for Rheumatology Research, University College London, Rayne Building for analysis of immune cell function through flow cytometry.
4 hours from point of sample collection
Analysis of serum
Tidsram: 4 hours from point of sample collection
Blood samples collected from consented participants containing serum will be appropriately sent to Dr Elizabeth Jury, Centre for Rheumatology Research, University College London, Rayne Building for measurement of chemokine, lipid expression and expression of other molecules important for immune cell activation.
4 hours from point of sample collection

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University College, London

Samarbetspartners

University College London Hospitals

Utredare

  • Huvudutredare: Rachel Farrell, Dr, UCL & University College London Hospitals NHS Foundation Trust

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 september 2018

Primärt slutförande (Förväntat)

1 juni 2020

Avslutad studie (Förväntat)

1 juni 2020

Studieregistreringsdatum

Först inskickad

5 augusti 2019

Först inskickad som uppfyllde QC-kriterierna

9 augusti 2019

Första postat (Faktisk)

12 augusti 2019

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

24 april 2020

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

22 april 2020

Senast verifierad

1 augusti 2019

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 18/0057

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

OBESLUTSAM

IPD-planbeskrivning

All participants indicate by written consent if they are willing to allow any of their un-used samples and associated data to be used for future research MS related research.

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Kliniska prövningar på Multipel skleros

Kliniska prövningar på Blood sampling

Sök liknande försök

Sponsorer och medarbetare

Medicinska tillstånd

Läkemedelsinterventioner

CROs by country

CROs in Colombia

Betingelser

Sällsynta sjukdomar

Läkemedelsinterventioner

Kosttillskott

Sponsor / medarbetare

Platser

3
Prenumerera