The Role of Lipids in Immune Cell Function in SLE Patients

Lupus Erythematosus, Systemic Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04361734
• Other study ID #: 15/0743
• Status: Recruiting
• Start date: February 15, 2016
• Est. completion date: August 31, 2020

Study information

• Verified date: April 2020
• Source: University College, London
• Contact: Liz Jury, Prof
• Phone: 02031082161
• Email: e.jury[@]ucl.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: August 31, 2020
• Est. primary completion date: August 31, 2020
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	University College London Hospitals NHS Foundation Trust	London

Sponsors (2)

Lead Sponsor	Collaborator
University College, London	University College London Hospitals

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Collection of blood samples	Blood sampling to measure immune cell phenotypes and examine DNA/RNA and identify serum biomarkers.	4 hours from point of sample collection
Primary	Completion of FFQ's and/or diet recall questionnaires	FFQ's and/or diet recall questionnaires to assess dietary intake	Same day as recruited to study.
Primary	Cardiovascular Ultrasound scans (USS)	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.