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The Role of Lipids in Immune Cell Function in SLE Patients

22 aprile 2020 aggiornato da: University College, London

Understanding the Role Played by Serum and Membrane Lipids in Immune Cell Function in Patients With Systemic Lupus Erythematosus (SLE) and Healthy Donors

The overall aim of this project is to investigate the different types of immune cells found in the blood of patients with Systemic Lupus Erythematosus (SLE) and healthy donors. We know that the amount of fat on the surface of immune cells is an important factor controlling their behaviour. Immune cells from SLE patients are defective and this is associated with changes in the levels of fat on these cells. This project will investigate the level of fat in the blood and on immune cells from patients with SLE and age matched healthy controls, and measure how changes in the amount of fat can affect the way immune cells behave.

Panoramica dello studio

Stato

Sconosciuto

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Accelerated atherosclerosis is a serious complication of autoimmunity including patients with both adult and juvenile onset systemic lupus erythematosus (SLE). This suggests that defects in fat levels could contribute to disease pathogenesis. The immune system in patients with SLE does not work normally. In adult patients with SLE we know that many of the immune cells involved in protecting the body from infections or cancer are over-active and actually cause disease. In young people the immune system is still developing and very little is known about what goes wrong in patients that develop juvenile-onset SLE, whether this is the same as adult disease and whether the same treatments are relevant for this group of patients. This project aims to find out whether immune cells from SLE patients with adult-onset disease have the same defects as adult patients with juvenile-onset SLE. We know that an important factor that controls immune cell behaviour is the amount of fat that they have on their surface. We also know that a change in fat on immune cells from adult patients with SLE makes them defective. This project will investigate the level of fat in the blood and in immune cells from adult patients with juvenile-onset SLE and age matched healthy controls, and measure how changes in the amount of fat can affect the way immune cells behave. We will investigate how drugs that control fat levels can help to normalize the behaviour of immune cells from SLE patients.

Tipo di studio

Osservativo

Iscrizione (Anticipato)

300

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Regno Unito
      • London, Regno Unito, NW1 2BU
        • Reclutamento
        • University College London Hospitals NHS Foundation Trust
        • Contatto:
        • Contatto:
        • Investigatore principale:
          • David Isenberg, Prof

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 80 anni (Adulto, Adulto più anziano)

Accetta volontari sani

N/A

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

Patients will be approached by the consultant rheumatologist when the patient is attending their normal outpatient clinic appointment.

Healthy donors will be approached in a similar way using information flyers, invitation letters and participant information sheets by a member of the research team.

Healthy volunteers from UCL staff will be made aware of the study and also asked to participate.

Descrizione

Inclusion Criteria:

  • Diagnosis of SLE according to American College of Rheumatology revised criteria
  • Having given written informed consent prior to undertaking any study-related procedures.
  • Male and female patients between the ages of 18 and 80 years.

Patients who have met all the above inclusion criteria listed and healthy donors will be screened for the following exclusion criteria:

Exclusion Criteria:

  • Under any administrative or legal supervision.
  • Conditions/situations such as:
  • A concomitant autoimmune disease
  • 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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
Juvenile onset Systemic Lupus Erythematosus (SLE) patients
All patients who meet the American College of Rheumatology revised criteria for SLE who were diagnosed with SLE between the ages of 11 and 21.
Altro: Blood sampling to include Deoxyribonucleic Acid (DNA) and Ribonucleic Acid (RNA)
  • Blood sampling to measure immune cell phenotypes and examine DNA/RNA and identify serum biomarkers.
  • Food Frequency Questionnaires (FFQs) and/or diet recall questionnaires to assess dietary intake.
  • Cardiovascular Ultrasound Scans (USS) to measure how well blood is carried around the body.
Altri nomi:
  • Food Frequency Questionnaires (FFQs) and/or 24 hour diet recall questionnaires
  • Ultrasound Scan (USS)
  • GTN (glyceryl trinitrate) administration
Adult onset Systemic Lupus Erythematosus (SLE) patients
All patients who meet the American College of Rheumatology revised criteria for SLE who were diagnosed with SLE between the ages of 24 and 80
Altro: Blood sampling to include Deoxyribonucleic Acid (DNA) and Ribonucleic Acid (RNA)
  • Blood sampling to measure immune cell phenotypes and examine DNA/RNA and identify serum biomarkers.
  • Food Frequency Questionnaires (FFQs) and/or diet recall questionnaires to assess dietary intake.
  • Cardiovascular Ultrasound Scans (USS) to measure how well blood is carried around the body.
Altri nomi:
  • Food Frequency Questionnaires (FFQs) and/or 24 hour diet recall questionnaires
  • Ultrasound Scan (USS)
  • GTN (glyceryl trinitrate) administration
Matching healthy volunteers
Healthy volunteers, matched by age and gender, will be used as a control group
Altro: Blood sampling to include Deoxyribonucleic Acid (DNA) and Ribonucleic Acid (RNA)
  • Blood sampling to measure immune cell phenotypes and examine DNA/RNA and identify serum biomarkers.
  • Food Frequency Questionnaires (FFQs) and/or diet recall questionnaires to assess dietary intake.
  • Cardiovascular Ultrasound Scans (USS) to measure how well blood is carried around the body.
Altri nomi:
  • Food Frequency Questionnaires (FFQs) and/or 24 hour diet recall questionnaires
  • Ultrasound Scan (USS)
  • GTN (glyceryl trinitrate) administration

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Collection of blood samples
Lasso di tempo: 4 hours from point of sample collection
Blood sampling to measure immune cell phenotypes and examine DNA/RNA and identify serum biomarkers.
4 hours from point of sample collection
Completion of FFQ's and/or diet recall questionnaires
Lasso di tempo: Same day as recruited to study.
FFQ's and/or diet recall questionnaires to assess dietary intake
Same day as recruited to study.
Cardiovascular Ultrasound scans (USS)
Lasso di tempo: Within 2 months from recruitment.
USS of Intima Media Thickness (IMT), Flow Mediated Dilatation (FMD), Pulse Wave Velocity (PWV) and Laser Doppler Flowmetry measurement. As part of the procedure, sub lingual administration of GTN spray will be administered to measure FMD.
Within 2 months from recruitment.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University College, London

Collaboratori

University College London Hospitals

Investigatori

  • Investigatore principale: David Isenberg, Prof, UCL & University College London Hospitals NHS Foundation Trust

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

15 febbraio 2016

Completamento primario (Anticipato)

31 agosto 2020

Completamento dello studio (Anticipato)

31 agosto 2020

Date di iscrizione allo studio

Primo inviato

22 aprile 2020

Primo inviato che soddisfa i criteri di controllo qualità

22 aprile 2020

Primo Inserito (Effettivo)

24 aprile 2020

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

24 aprile 2020

Ultimo aggiornamento inviato che soddisfa i criteri QC

22 aprile 2020

Ultimo verificato

1 aprile 2020

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 15/0743

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Descrizione del piano IPD

All participants are required to indicate in written consent if they agree to the use of any left over samples and associated data for future research use.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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