The Role of Lipids in Immune Cell Function in SLE Patients

NCT ID: NCT04361734

Last Updated: 2020-04-24

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-02-15
• Study Completion Date: 2020-08-31

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.

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.

Conditions

Lupus Erythematosus, Systemic

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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.

Blood sampling to include Deoxyribonucleic Acid (DNA) and Ribonucleic Acid (RNA)

Intervention Type: OTHER

• 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.

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

Blood sampling to include Deoxyribonucleic Acid (DNA) and Ribonucleic Acid (RNA)

Intervention Type: OTHER

• 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.

Matching healthy volunteers

Healthy volunteers, matched by age and gender, will be used as a control group

Blood sampling to include Deoxyribonucleic Acid (DNA) and Ribonucleic Acid (RNA)

Intervention Type: OTHER

• 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.

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

Food Frequency Questionnaires (FFQs) and/or 24 hour diet recall questionnaires; Ultrasound Scan (USS); GTN (glyceryl trinitrate) administration

Eligibility 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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University College London Hospitals

OTHER

Sponsor Role: collaborator

University College, London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Isenberg, Prof

Role: PRINCIPAL_INVESTIGATOR

UCL & University College London Hospitals NHS Foundation Trust

Locations

University College London Hospitals NHS Foundation Trust

London, , United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Liz Jury, Prof

Role: CONTACT

e.jury@ucl.ac.uk

02031082161

George Robinson, Dr

Role: CONTACT

george.robinson.15@ucl.ac.uk

02031082167

Facility Contacts

George Robinson, Dr

Role: primary

george.robinson.15@ucl.ac.uk

02031082167

Amanda Ledlie

Role: backup

a.ledlie@ucl.ac.uk

02031082167

Other Identifiers

15/0743

Identifier Type: -

Identifier Source: org_study_id