Actively Recruiting

Age: 18Years - 80Years
All Genders
ID06914778

Investigating Metabolic and Lipid Profiles Associated With Different Stages of Diabetic Maculopathy and Retinopathy in South Wales

Led by Hywel Dda Health Board · Updated on 2025-04-10

120

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

H

Hywel Dda Health Board

Lead Sponsor

U

University of Aberdeen

Collaborating Sponsor

AI-Summary

What this Trial Is About

Diabetic Retinopathy (DR) is a common complication of diabetes that damages the small blood vessels in the retina, potentially leading to vision loss. Researchers are studying the metabolic and lipid profiles in people with type 2 diabetes at different stages of DR to better understand the disease's underlying mechanisms. This observational study aims to identify chemicals in the blood and the role of gut bacteria that may influence retinal damage and diabetic eye disease progression. Participants will provide blood and urine samples for detailed lipidomic and metabolomic analyses, while researchers will review medical records, previous eye photographs, and specialized retinal scans to classify the severity of DR. The study groups include patients at various stages of diabetic eye disease, ranging from no retinopathy to proliferative DR and diabetic macular edema (DMO) without prior treatment. Sample collection is coordinated with routine clinic visits to minimize participant burden. During the study, participants’ data and biological samples will be securely collected and anonymized. Researchers will analyze blood plasma and urine metabolites over several years to explore potential biomarkers and mechanisms related to DR severity. The primary outcome is the analysis of serum lipid profiles associated with DR, supported by secondary analyses of metabolic pathways and microbiome interactions. The study is planned to start recruiting in early 2025, with ongoing sample analysis continuing until 2030.

CONDITIONS

Brief Title

Investigating the Metabolic and Lipidomic Profiles That Are Associated With Varying Grades of Diabetic Maculopathy and Retinopathy in South Wales

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of type 2 diabetes mellitus
  • Male or female aged 18 to 80 years inclusive
Not Eligible

You will not qualify if you...

  • Unable or unwilling to give consent to participate
  • Previous treatment with intravitreal therapies for diabetic macular edema
  • Known infectious diseases that may risk study staff (e.g., tuberculosis, HIV, hepatitis)
  • Age less than 18 or over 80 years
  • Known genetic condition affecting lipid metabolism

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - Up to 12 months

Participants who undergo routine diabetes care and ophthalmic assessments provide blood and urine samples for lipidomic and metabolomic analysis to investigate changes associated with diabetic retinopathy.

Sample collection during routine clinic visits

Long-term Monitoring

Duration - Up to 5 years from sample collection

Participants’ blood plasma and urine metabolites and lipids are analyzed over several years to identify potential biomarkers and understand metabolic pathways related to diabetic retinopathy.

No additional visits; analysis performed on collected samples

Trial Site Locations

Total: 1 location

1

Prince Philip Hospital

Llanelli, Wales, United Kingdom, SA14 8QF

Actively Recruiting

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Research Team

F

Francis WB Sanders, MB BChir PhD FRCOphth

E

Eirini Skiadaresi

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

6

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Published Research Related To This Trial

A comparison of the causes of blindness certifications in England and Wales in working age adults (16-64 years), 1999-2000 with 2009-2010.

Gerald Liew, Michel Michaelides, Catey Bunce

https://pubmed.ncbi.nlm.nih.gov/24525390

Diminished retinal complex lipid synthesis and impaired fatty acid β-oxidation associated with human diabetic retinopathy.

Patrice E Fort, Thekkelnaycke M Rajendiran, Tanu Soni...

https://pubmed.ncbi.nlm.nih.gov/34437304

ELOVL4-Mediated Production of Very Long-Chain Ceramides Stabilizes Tight Junctions and Prevents Diabetes-Induced Retinal Vascular Permeability.

Nermin M Kady, Xuwen Liu, Todd A Lydic...

https://pubmed.ncbi.nlm.nih.gov/29362226