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The Role of Lipids in Immune Cell Function in SLE Patients

22. april 2020 opdateret af: 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.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

300

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Det Forenede Kongerige
      • London, Det Forenede Kongerige, NW1 2BU
        • Rekruttering
        • University College London Hospitals NHS Foundation Trust
        • Kontakt:
        • Kontakt:
        • Ledende efterforsker:
          • David Isenberg, Prof

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

N/A

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
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.
Andet: 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.
Andre navne:
  • 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
Andet: 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.
Andre navne:
  • 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
Andet: 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.
Andre navne:
  • Food Frequency Questionnaires (FFQs) and/or 24 hour diet recall questionnaires
  • Ultrasound Scan (USS)
  • GTN (glyceryl trinitrate) administration

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Collection of blood samples
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University College, London

Samarbejdspartnere

University College London Hospitals

Efterforskere

  • Ledende efterforsker: David Isenberg, Prof, UCL & University College London Hospitals NHS Foundation Trust

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

15. februar 2016

Primær færdiggørelse (Forventet)

31. august 2020

Studieafslutning (Forventet)

31. august 2020

Datoer for studieregistrering

Først indsendt

22. april 2020

Først indsendt, der opfyldte QC-kriterier

22. april 2020

Først opslået (Faktiske)

24. april 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

24. april 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. april 2020

Sidst verificeret

1. april 2020

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 15/0743

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

IPD-planbeskrivelse

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Kliniske forsøg med Lupus erythematosus, systemisk

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