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.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | Hywel Dda Health Board Academic / other |
| Locations | 1 site (Llanelli, Wales) |
| Status | Recruiting |
| Started | March 31, 2025 |
| Main results expected | January 1, 2030 |
| Study ends | January 1, 2030 |
| Registry record updated | April 10, 2025 |
| Trial ID | NCT06914778 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.
-
Early imaging changes with faricimab versus biosimilar ranibizumab for diabetic retinal disease
This trial will see if faricimab or a biosimilar ranibizumab causes different early OCT and OCTA imaging changes in adults with diabetic retinopathy or diabetic macular edema who need anti-VEGF injections.
-
New-generation diabetes medicines and the onset of diabetic retinopathy
This study will test whether newer diabetes medicines (SGLT2 and DPP‑4 inhibitors) can delay diabetic retinopathy in people with type 2 diabetes who've had the disease for more than five years and have been on diabetes medications for 2–3 years.
-
Oral N-Acetylcysteine for Diabetic Macular Edema
This study tests whether taking N-acetylcysteine by mouth can help people with center-involving diabetic macular edema who don’t yet need anti-VEGF therapy.
-
4D-150 gene therapy injected into the eye for adults with diabetic macular edema
This study tests whether a one-time intravitreal injection of 4D-150 can help adults with diabetic macular edema compare to aflibercept.
-
Automated AI system to detect diabetic retinopathy in adults with diabetes
A AI-based software device is being tested to automatically detect diabetic retinopathy from retinal images in adults with diabetes.
-
Corticosteroid for Diabetic Macular Edema (DME) in Adults with Diabetic Retinopathy
This trial tests whether intravitreal corticosteroid injections can influence inflammatory biomarkers and improve DME in adults with type 2 diabetes.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.