Genetic Variants and Regulation of Specialized Pro-resolving Mediator
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorQueen Mary University of London
About this trial
Inflammation is the way that the body reacts against infection, injury or illness. An uncontrolled inflammatory response can lead to the development of inflammatory diseases, such as rheumatoid arthritis and cardiovascular conditions. Recent studies have shown that inflammation is a regulated process coordinated by a group of molecules known as specialized pro-resolving mediator (SPM). These molecules are produced by enzymes via the enzymatic conversion of essential fatty acids; whereas their biological actions are mediated by proteins expressed on the surface of cells known as receptors.
Given the central role that pro-resolving mediators play in regulating the immune response, the aim of this study is to investigate whether there are genetic variants (mutations) in genes encoding for enzymes and receptors involved in the biology of these molecules and to determine how these mutations affect SPM's activity or function.
Findings made as part of these studies will help shed light into mechanism influencing disease onset and/or progression and potentially enhance the discovery of new and more effective treatments.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Current volunteer of the Genes & Health program with (test) or without (control) relevant genetic mutations. Genes & Health is a huge long-term study of 100,000 people of Bangladeshi and Pakistani origin focuses to link genes with health records and to study disease and treatments. When a volunteer participates in this program, they agree to the possibility to be invited for further studies. Gene & Health program invites volunteers to take part in two regions of the UK: East London and Bradford.
Disqualifiers
Volunteer that has not had their genome sequenced after taking part in Stage 1 of Genes & Health program.
Volunteer with significant genetically inherited conditions.
Any abnormality or pre-existing disease which, in the opinion of the investigator, might either expose the subject to risk, or influence the validity of the results.
Volunteer that went under surgery and are recovering.
Trial population
Genes \& Health is a huge long-term study of 100,000 people of Bangladeshi and Pakistani origin focuses to link genes with health records and to study disease and treatments. We will be focused on those volunteers with specific mutations in Specialized pro-resolving mediators enzymes and receptors.
Trial design
Design model
Case-control
Time perspective
Cross-sectional
Treatments tested in this trial
Blood Donation
Procedure/SurgeryThe blood donation will take place at the Gene \& Health clinical assessment centre facilities. A trained member from Gene \& Health program will be responsible for taking the blood samples.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Controls1 intervention
Group B: Cases1 intervention
Trial outcomes
Primary outcomes
1
Lipid Mediator Profiling
The blood samples will be used to get the lipid mediator profiling (specialized pro-resolving mediators abundance in blood) using a liquid chromatography in tandem mass spectrometry strategy).
Time frame
Inmediately after blood sample collection.Secondary outcomes
1
Phagocytosis
Phagocytosis will be assayed in vitro by measuring the engulfment of Escherichia coli by T cells and Macrophage. The extent of phagocytosis will be assessed using flow cytometry.
Time frame
Up to 6 month after blood sample collection.2
Platelet activation
Adhesion molecule expression as well as platelet-leukocyte aggregates will be assessed using flow cytometry.
Time frame
Up to 6 month after blood sample collection.3
Peripheral blood T-cell assay
T-cell activity will be assessed using cytokine expression as well as the expression of activation markers by flow cytometry.
Time frame
Up to 6 month after blood sample collection.4
Peripheral blood SPM pathways
Enzyme and receptor expression associated with specialized pro resolving mediators will be assessed using flow cytometry.
Time frame
Up to 6 month after blood sample collection.Other outcomes
1
Genetic variants associations
In addition, volunteers will consent for access to their centralised health records so we can identify associations between different mutations and the development of inflammatory conditions.
Time frame
6 months after patient recruitment.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov