Investigating metabolic and lipid profiles in diabetic eye disease
Investigating the Metabolic and Lipidomic Profiles That Are Associated With Varying Grades of Diabetic Maculopathy and Retinopathy in South Wales
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 |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Hywel Dda Health Board Academic / other |
| Locations | 1 site (Llanelli, Wales) |
| Trial ID | NCT06914778 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 80 with a diagnosis of type 2 diabetes mellitus.
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.
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 performed: While there is limited evidence from small population studies, this approach is relatively novel and has not been extensively tested in broader cohorts.
Eligibility criteria
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 this trial is running
Llanelli, Wales
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.