Genetic Variants and Regulation of Specialized Pro-resolving Mediator

NCT04698291 | Recruiting

• 1 other identifier: 291815
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy; Inflammatory Disease; Cardiovascular Diseases

Outcome Measures

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).

  Inmediately after blood sample collection.

Secondary Outcomes (4)

• Phagocytosis

  Up to 6 month after blood sample collection.

• Platelet activation

  Up to 6 month after blood sample collection.

• Peripheral blood T-cell assay

  Up to 6 month after blood sample collection.

• Peripheral blood SPM pathways

  Up to 6 month after blood sample collection.

Other Outcomes (1)

• Genetic variants associations

  6 months after patient recruitment.

Study Arms (2)

Controls

This research aims to recruit only adult volunteers that have taken part of the Gene \& Health program. We will focus on two groups: individuals presenting the polymorphisms of interest and individuals without the genetic variants in the genes of interest, which will be used as matched controls. Eligible individuals will consent to donate blood samples for this study, in addition to consent access to their medical and health records.

Procedure: Blood Donation

Cases

This research aims to recruit only adult volunteers that have taken part of the Gene \& Health program. We will focus on two groups: individuals presenting the polymorphisms of interest and individuals without the genetic variants in the genes of interest, which will be used as matched controls. Eligible individuals will consent to donate blood samples for this study, in addition to consent access to their medical and health records.

Procedure: Blood Donation

Interventions

Blood Donation PROCEDURE

The 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.

Cases; Controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Participation in a clinical study of a new chemical entity, biological product or a prescription medicine, or loss of more than 400 mL blood, within the previous 3 months.
• Presence or history of drug or alcohol abuse.

Sponsors & Collaborators

• Queen Mary University of London: lead

Study Sites (1)

Queen Mary University of London

London, EC1M 6BQ, United Kingdom

RECRUITING

Related Links

• Gene \& Health program information

Biospecimen

Retention: SAMPLES WITH DNA

Whole Blood

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Blood Donation

Intervention Hierarchy (Ancestors)

Tissue and Organ Procurement; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Jesmond Dalli, Professor

  Queen Mary University of London

  STUDY DIRECTOR

Central Study Contacts

Esteban A Gomez Cifuentes, PhD student

CONTACT

+447741093970; e.a.g.c.cifuentes@qmul.ac.uk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2020
• First Posted: January 6, 2021
• Study Start: May 6, 2021
• Primary Completion (Estimated): October 5, 2027
• Study Completion (Estimated): December 8, 2027
• Last Updated: February 5, 2026

Record last verified: 2026-02

Locations

GB (1)