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 volunteersQualifiers
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
Case-control
Cross-sectional
Treatments tested in this trial
Blood draw for the laboratory assessment
Other interventionBlood plasma collection for for lipidomic and metabolomic analysis
Urine sample
Other interventionUrine sampling for aqueous metabolomics
Treatment groups
6
Treatment groupsSee each treatment group below.
Trial outcomes
Primary outcomes
Analysis of serum lipidome of people with differing severity of DR
To investigate the serum lipidome in people with differing severity of DR
Secondary outcomes
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
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
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
Sponsors and contacts
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Hywel Dda Health Board
Lead sponsor
University of Aberdeen
Collaborator