Lupus Erythematosus, SystemicNCT04361734
The Role of Lipids in Immune Cell Function in SLE Patients
An observational study of Lupus Erythematosus, Systemic, run by University College, London at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lupus Erythematosus, Systemic
- What is being tested?
- Blood sampling to include Deoxyribonucleic Acid (DNA) and Ribonucleic Acid (RNA)
- How many people
- 300 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Feb 2016to 31 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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:
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University College London Hospitals NHS Foundation Trust
London, NW1 2BU
George Robinson, Dr, 02031082167, george.robinson.15@ucl.ac.uk
Amanda Ledlie, 02031082167, a.ledlie@ucl.ac.uk
About this study
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
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.
Read the 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
- Being tested
- Blood sampling to include Deoxyribonucleic Acid (DNA) and Ribonucleic Acid (RNA)
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampling to include Deoxyribonucleic Acid (DNA) and Ribonucleic Acid (RNA)Other
Also called Food Frequency Questionnaires (FFQs) and/or 24 hour diet recall questionnaires, Ultrasound Scan (USS), GTN (glyceryl trinitrate) administration
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Blood sampling to include Deoxyribonucleic Acid (DNA) and Ribonucleic Acid (RNA) | |
| 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 Receives: Other: Blood sampling to include Deoxyribonucleic Acid (DNA) and Ribonucleic Acid (RNA) | |
| Matching healthy volunteers | Healthy volunteers, matched by age and gender, will be used as a control group Receives: Other: Blood sampling to include Deoxyribonucleic Acid (DNA) and Ribonucleic Acid (RNA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collection of blood samples
Blood sampling to measure immune cell phenotypes and examine DNA/RNA and identify serum biomarkers.
Measured: 4 hours from point of sample collection
Completion of FFQ's and/or diet recall questionnaires
FFQ's and/or diet recall questionnaires to assess dietary intake
Measured: Same day as recruited to study.
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.
Measured: Within 2 months from recruitment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start15 Feb 2016
- Primary completion31 Aug 2020 (estimated)
- Study completion31 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lupus Erythematosus, SystemicStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- University College London Hospitals
- Responsible party
- Sponsor
- Investigators
- David Isenberg, Prof, Principal investigator, UCL & University College London Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04361734
- Sponsor's protocol ID
- 15/0743
- Status last verified
- Apr 2020
- First submitted
- 22 Apr 2020
- Last updated
- 24 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04361734
- Acronym / sponsor ID
- 15/0743
- Conditions
- Lupus Erythematosus, Systemic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- University College London Hospitals
- Study start
- 15 Feb 2016 (actual)
- Primary completion
- 31 Aug 2020 (estimated)
- Study completion
- 31 Aug 2020 (estimated)
- First posted
- 24 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Juvenile onset Systemic Lupus Erythematosus (SLE) patients | – | Other: Blood sampling to include Deoxyribonucleic Acid (DNA) and Ribonucleic Acid (RNA)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. |
| Adult onset Systemic Lupus Erythematosus (SLE) patients | – | Other: Blood sampling to include Deoxyribonucleic Acid (DNA) and Ribonucleic Acid (RNA)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 |
| Matching healthy volunteers | – | Other: Blood sampling to include Deoxyribonucleic Acid (DNA) and Ribonucleic Acid (RNA)Healthy volunteers, matched by age and gender, will be used as a control group |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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:
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sampling to include Deoxyribonucleic Acid (DNA) and Ribonucleic Acid (RNA)Also: Food Frequency Questionnaires (FFQs) and/or 24 hour diet recall questionnaires, Ultrasound Scan (USS), GTN (glyceryl trinitrate) administration* 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 | Adult onset Systemic Lupus Erythematosus (SLE) patients, Juvenile onset Systemic Lupus Erythematosus (SLE) patients, Matching healthy volunteers |
Primary outcome
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.
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
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2020.
- Individual participant dataSharing planned: Undecided. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Isenberg, Prof principal investigator
UCL & University College London Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lupus Erythematosus, Systemic, run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liz Jury, Prof (02031082161, e.jury@ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collection of blood samples (time frame: 4 hours from point of sample collection). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2020.