Clinical trial Recruiting at 1 site Observational Ages 18 to 80

Investigating metabolic and lipid profiles in diabetic eye disease

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

Run by Hywel Dda Health Board · NCT06914778 · Data updated 2026-11-12

This study is trying to see how blood and urine samples from people with diabetes relate to eye damage caused by diabetic eye disease and if gut bacteria play a role in this.

More Diabetic Retinopathy (DR) trials

Quick facts

Study typeObservational
Ages18 Years to 80 Years
SexAll
Enrollment120 (estimated)
SponsorHywel Dda Health Board
Academic / other
Locations1 site (Llanelli, Wales)
StatusRecruiting
StartedMarch 31, 2025
Main results expectedJanuary 1, 2030
Study endsJanuary 1, 2030
Registry record updatedApril 10, 2025
Trial IDNCT06914778 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include adults aged 18 to 80 with a diagnosis of type 2 diabetes mellitus.

Probably not a fit

Patients under 18 or over 80, those with prior intravitreal treatments for diabetic macular edema, or those with known infectious diseases may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to recruit individuals with diabetes and varying stages of diabetic eye disease to analyze blood and urine samples for metabolic and lipidomic profiles. The research will explore the relationship between these profiles and the damage to the retina caused by diabetic retinopathy and diabetic macular edema. Additionally, the study will examine gut bacteria that may influence eye disease through circulating chemicals. Participants will have their medical records reviewed to support the findings.

Why it matters

Potential benefit: If successful, this study could lead to better understanding and management of diabetic eye diseases, potentially improving patient outcomes.

How similar studies have gone: While there is limited evidence from small population studies, this approach is relatively novel and has not been extensively tested in broader cohorts.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Diagnosis of type 2 diabetes mellitus
* Male or female aged 18 - 80 inclusive

Exclusion Criteria:

* Participant unable or unwilling to consent to inclusion in the study
* Prior treatment with intravitreal therapies for DMO
* Potential participant with a known infective disease that may put the study team at risk (eg. TB, HIV, hepatitis)
* Age 17 yo or less or 81 yo or older
* Known underlying genetic condition affecting lipid metabolism

Where it's running

  • Prince Philip Hospital
    Llanelli, Wales, United Kingdom
    Recruiting

Study contacts

  • Principal investigator: Francis WB Sanders, MB BChir PhD FRCOphth — Hywel Dda University Health Board
  • Study coordinator: Francis WB Sanders, MB BChir PhD FRCOphth
  • Email: francis.sanders@wales.nhs.uk
  • Phone: +447717171199

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.