Studies blood and urine markers in people with diabetic eye disease
Compares blood and gut bacteria chemicals in adults with diabetes-related eye damage.
Key facts
- Who runs it
- Hywel Dda Health Board
- Where
- Llanelli, United KingdomSee the site
- Trial code
- Registry title
- Investigating the Metabolic and Lipidomic Profiles That Are Associated With Varying Grades of Diabetic Maculopathy and Retinopathy in South Wales
- Status
- Recruiting
- People taking part
- 120 people, planned
- Started
- 31 Mar 2025
- Expected to end
- 1 Jan 2030
- Type of study
- Observational, 6 groups
- Treatments tested
- Blood draw for the laboratory assessment
- Urine sample
- Record updated
- 10 April 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with type 2 diabetes, with or without diabetic eye disease. They give blood and urine samples, and the researchers look at their eye records and scans.
- Age
- 18 to 80 years, both included.
- Sex
- Men and women can join.
- Disease stage
- Type 2 diabetes. The record does not name a required stage of eye disease.
- Earlier treatment
- People who have had intravitreal treatment (injections into the eye) for diabetic macular oedema (DMO) cannot join.
Main reasons for not taking part
- Cannot or does not want to give consent
- Earlier intravitreal treatment for DMO
- Known infectious disease that could put the study team at risk (for example TB, HIV, hepatitis)
- Age 17 or younger, or 81 or older
- Known genetic condition affecting lipid (fat) metabolism
The registry criteria, word for word
Show all 7 criteriaShow less
Who can take part
- Diagnosis of type 2 diabetes mellitus
- Male or female aged 18 - 80 inclusive
Who cannot take part
- 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)
- Known underlying genetic condition affecting lipid metabolism
- Age 17 yo or less or 81 yo or older
- Participant unable or unwilling to consent to inclusion in the study
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Where in United Kingdom
- Prince Philip HospitalLlanelli, United KingdomContact: Francis WB Sanders, MB BChir PhD FRCOphthTaking people
About the trial
What the trial wants to find out
Diabetes mellitus is a disorder of sugar and fat metabolism which results in damage to the small blood vessels in various organs, this includes the retina - the part of the eye that processes light into a nerve impulse. This leads to damage and blindness via various different mechanisms that are not fully understood.
Read full original descriptionShow less
In this study the objective is to recruit people with diabetes and various stages of diabetic eye disease and measure a large number of different chemicals within the blood that might be associated with damage and dysfunction within the retina. Additionally, it will examine the different bacteria within the gut that might affect disease in the eye via chemicals circulating in the blood. This will require participants to have blood samples taken and to provide urine samples. The blood will be analysed with specialised instruments to identify specific molecules circulating within the blood. Participants will also need to allow researchers to look at their medical records, previous photographs and specialist scans of the back of the eye to grade their diabetic retinopathy. This will allow us to identify potential ways in which these could be targeted for future benefit for people with diabetes to hopefully prevent deterioration of their vision.
The 6 groups in the trial
- Group 1 - No diabetic retinopathy or maculopathy
Group 1 - Patients with type 2 DM but No diabetic retinopathy or maculopathy
Treatment: Blood draw for the laboratory assessment and Urine sample
- Group 2 - Mild preproliferative DR
Group 2 - Patients with Type 2 diabetes and Mild preproliferative DR
Treatment: Blood draw for the laboratory assessment and Urine sample
- Group 3 - Moderate Pre-proliferative DR
Group 3 - Patients with type 2 diabetes and Moderate Pre-proliferative DR
Treatment: Blood draw for the laboratory assessment and Urine sample
- Group 4 - Severe pre-proliferative DR
Group 4 - Patients with type 2 diabetes and Severe pre-proliferative DR
Treatment: Blood draw for the laboratory assessment and Urine sample
- Group 5 - Proliferative DR
Group 5 - Patients with type 2 diabetes and Proliferative DR
Treatment: Blood draw for the laboratory assessment and Urine sample
- Group 6 - DMO with any degree of DR and no prior treatment
Group 6 - Patients with type 2 diabetes and DMO with any degree of DR and no prior treatment
Treatment: Blood draw for the laboratory assessment and Urine sample
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Investigating the Metabolic and Lipidomic Profiles That Are Associated With Varying Grades of Diabetic Maculopathy and Retinopathy in South Wales
- Plain-language title
- Studies blood and urine markers in people with diabetic eye diseaseGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT06914778, who can take part
- Record updated
- 10 April 2025