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The Role of Lipids in Immune Cell Function in SLE Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04361734
Recruitment Status : Recruiting
First Posted : April 24, 2020
Last Update Posted : April 24, 2020
Sponsor:
Collaborator:
University College London Hospitals
Information provided by (Responsible Party):
University College, London

Brief Summary:
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.

Condition or disease Intervention/treatment
Lupus Erythematosus, Systemic Other: Blood sampling to include Deoxyribonucleic Acid (DNA) and Ribonucleic Acid (RNA)

Detailed Description:
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.

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Understanding the Role Played by Serum and Membrane Lipids in Immune Cell Function in Patients With Systemic Lupus Erythematosus (SLE) and Healthy Donors
Actual Study Start Date : February 15, 2016
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Group/Cohort Intervention/treatment
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.
Other: 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.
Other Names:
  • 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
Other: 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.
Other Names:
  • 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
Other: 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.
Other Names:
  • Food Frequency Questionnaires (FFQs) and/or 24 hour diet recall questionnaires
  • Ultrasound Scan (USS)
  • GTN (glyceryl trinitrate) administration




Primary Outcome Measures :
  1. Collection of blood samples [ Time Frame: 4 hours from point of sample collection ]
    Blood sampling to measure immune cell phenotypes and examine DNA/RNA and identify serum biomarkers.

  2. Completion of FFQ's and/or diet recall questionnaires [ Time Frame: Same day as recruited to study. ]
    FFQ's and/or diet recall questionnaires to assess dietary intake

  3. Cardiovascular Ultrasound scans (USS) [ Time Frame: 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.


Biospecimen Retention:   Samples With DNA
Blood, DNA


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04361734


Contacts
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Contact: Liz Jury, Prof 02031082161 e.jury@ucl.ac.uk
Contact: George Robinson, Dr 02031082167 george.robinson.15@ucl.ac.uk

Locations
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United Kingdom
University College London Hospitals NHS Foundation Trust Recruiting
London, United Kingdom, NW1 2BU
Contact: George Robinson, Dr    02031082167    george.robinson.15@ucl.ac.uk   
Contact: Amanda Ledlie    02031082167    a.ledlie@ucl.ac.uk   
Principal Investigator: David Isenberg, Prof         
Sponsors and Collaborators
University College, London
University College London Hospitals
Investigators
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Principal Investigator: David Isenberg, Prof UCL & University College London Hospitals NHS Foundation Trust
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Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT04361734    
Other Study ID Numbers: 15/0743
First Posted: April 24, 2020    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: 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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Nitroglycerin
Vasodilator Agents