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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorHywel Dda Health Board

About this trial

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.

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of type 2 diabetes mellitus

Male or female aged 18 - 80 inclusive

Disqualifiers

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

Trial population

Patients with type 2 diabetes mellitus under the care of Hywel Dda Univesity Health Board Department of Ophthalmology

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

  • Blood draw for the laboratory assessment

    Other intervention

    Blood plasma collection for for lipidomic and metabolomic analysis

  • Urine sample

    Other intervention

    Urine sampling for aqueous metabolomics

Treatment groups

120 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Group 1 - No diabetic retinopathy or maculopathy2 interventions
Group B: Group 2 - Mild preproliferative DR2 interventions
Group C: Group 3 - Moderate Pre-proliferative DR2 interventions
Group D: Group 4 - Severe pre-proliferative DR2 interventions
Group E: Group 5 - Proliferative DR2 interventions
Group F: Group 6 - DMO with any degree of DR and no prior treatment2 interventions

Trial outcomes

Primary outcomes

1

Analysis of serum lipidome of people with differing severity of DR

To investigate the serum lipidome in people with differing severity of DR

Time frame
5 years

Secondary outcomes

1

Metabolic pathway analysis with reference to diabetic maculopathy

\- To compare the lipidomic markers in those with and without diabetic maculopathy to gain potential mechanistic insight

Time frame
5 years
2

Metabolic pathway analysis with additional analysis of interaction with microbiome

\- To investigate the interaction of circulating markers associated with the microbiome and how it might influence lipid metabolism in the retina and the severity of DR expressed by an individual

Time frame
5 years
3

Metabolic pathway analysis with reference to altered lipid metabolism

\- To map the lipid metabolism pathways that might contribute to development of differing grades of DR

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hywel Dda Health Board

Lead sponsor

University of Aberdeen

Collaborator