RecruitingOBSERVATIONAL

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

This study aims to understand why diabetes causes damage to the small blood vessels in the eye, which can lead to vision problems. We're inviting people with different stages of diabetes-related eye damage to take part. We'll take blood and urine samples to look at specific chemicals in your body. We'll also examine the bacteria in your gut, as this might also play a role in eye health. We believe these factors could be linked to how your vision is affected. By finding these connections, we hope to discover new ways to protect the eyesight of people with diabetes in the future.

At a glance

Status

Recruiting

Sponsor

Hywel Dda Health Board

Enrolment target

120

Start

31 Mar 2025

Estimated completion

01 Jan 2030

Diabetic Retinopathy (DR)Diabetic Retinopathy Associated With Type 2 Diabetes Mellitus Diabetic Macular Edema (DME)

What is this study about?

Diabetes affects how your body handles sugar and fats, and over time, this can damage tiny blood vessels, including those in the retina at the back of your eye. This damage can lead to problems with your vision and, in some cases, blindness. Scientists don't fully understand all the reasons why this happens.

This study in South Wales is looking to understand this more deeply. We're inviting people with diabetes who have different levels of eye damage to participate. Our goal is to measure many different chemicals in blood and urine samples to see if any of these are linked to problems in the eye. We're also curious about the bacteria in your gut, as there's growing evidence that gut health can affect other parts of your body, including your eyes.

By carefully analysing these samples and reviewing your medical notes and eye scans, we hope to find patterns. Identifying these patterns could help us understand what causes eye damage in diabetes. Ultimately, this knowledge could lead to new treatments or ways to prevent vision loss for people with diabetes in the future.

Key takeaways

Study explores links between body chemicals, gut bacteria, and diabetic eye damage.
Aims to understand why diabetes affects eyesight.
Participation involves blood and urine samples, and medical record review.
Research could lead to new ways to protect vision in people with diabetes.
No direct personal benefits or new medications involved.
Your privacy and right to withdraw are protected.

Who may be eligible?

You might be able to take part if you have type 2 diabetes and are aged between 18 and 80 years old, inclusive. Both men and women are welcome to participate.

However, you won't be able to join if you can't or don't want to give your consent to be in the study, or if you've already had certain treatments for your eye condition called DMO (diabetic macular oedema) injections.

Also, if you have a known infectious disease that could put the study team at risk (like TB, HIV, or hepatitis), or a known genetic condition that affects how your body processes fats, you wouldn't be suitable for this study.

Quick self-check

Do I have type 2 diabetes?
Am I between 18 and 80 years old?
Have I had intravitreal therapies (injections) for DMO in the past?
Do I have any known infectious diseases like TB, HIV, or hepatitis?
Do I have a known genetic condition affecting how my body processes fats?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, you will be asked to give blood samples and urine samples. These samples will be carefully analysed in a lab to look for specific chemicals. You will also need to allow the researchers to look at your medical records, including any past eye photographs and special scans of the back of your eye. This will help them understand the stage of your diabetic eye condition. The study doesn't involve any new medication or extra appointments beyond providing samples and allowing access to your existing medical information. The total duration of your participation would involve the sample collection and data review, the exact timeframe for which would be explained by the study team.

Potential risks and benefits

Taking part in this study could help us learn more about diabetic eye disease, which might lead to better ways to prevent vision loss in the future for people with diabetes. The risks are minimal; you might feel a slight pinch or bruise from the blood test, similar to a routine doctor's visit. There are no direct personal benefits to you from participating. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Prince Philip Hospital
Llanelli, United Kingdom· Recruiting

Common questions

What is diabetic maculopathy and retinopathy?

These are eye conditions caused by diabetes. Retinopathy affects the tiny blood vessels in the retina (the light-sensitive part at the back of your eye), and maculopathy affects the macula, which is the part of your retina responsible for sharp, central vision.

Why are you looking at gut bacteria?

Recent research suggests that there might be a link between the types of bacteria in your gut and other health conditions, including eye health. We want to see if gut bacteria play a role in diabetic eye damage.

Will taking part improve my eyesight?

This study is for research purposes, and it's unlikely to directly improve your eyesight. However, the information we gather could help future patients.

What will happen to my blood and urine samples?

Your samples will be analysed by experts in a laboratory to identify different chemicals and molecules that might be linked to diabetic eye disease.

Is my personal information kept private?

Yes, all your personal and medical information will be kept strictly private and confidential, following all privacy regulations.

How to find out more

Francis WB Sanders, MB BChir PhD FRCOphth

francis.sanders@wales.nhs.uk +447717171199 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.