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

NCT06914778 | Recruiting

• 1 other identifier: 345156
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

diabetic retinopathy; lipidomics; ophthalmology; diabetic maculopathy; metabolomics

Outcome Measures

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

  5 years

Secondary Outcomes (3)

• Metabolic pathway analysis with reference to diabetic maculopathy

  5 years

• Metabolic pathway analysis with additional analysis of interaction with microbiome

  5 years

• Metabolic pathway analysis with reference to altered lipid metabolism

  5 years

Study Arms (6)

Group 1 - No diabetic retinopathy or maculopathy

Group 1 - Patients with type 2 DM but No diabetic retinopathy or maculopathy

Other: Blood draw for the laboratory assessment; Other: Urine sample

Group 2 - Mild preproliferative DR

Group 2 - Patients with Type 2 diabetes and Mild preproliferative DR

Other: Blood draw for the laboratory assessment; Other: Urine sample

Group 3 - Moderate Pre-proliferative DR

Group 3 - Patients with type 2 diabetes and Moderate Pre-proliferative DR

Other: Blood draw for the laboratory assessment; Other: Urine sample

Group 4 - Severe pre-proliferative DR

Group 4 - Patients with type 2 diabetes and Severe pre-proliferative DR

Other: Blood draw for the laboratory assessment; Other: Urine sample

Group 5 - Proliferative DR

Group 5 - Patients with type 2 diabetes and Proliferative DR

Other: Blood draw for the laboratory assessment; Other: 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

Other: Blood draw for the laboratory assessment; Other: Urine sample

Interventions

Blood draw for the laboratory assessment OTHER

Blood plasma collection for for lipidomic and metabolomic analysis

Also known as: Blood sample collection for lipidomics and metabolomics

Group 1 - No diabetic retinopathy or maculopathy; Group 2 - Mild preproliferative DR; Group 3 - Moderate Pre-proliferative DR; Group 4 - Severe pre-proliferative DR; Group 5 - Proliferative DR; Group 6 - DMO with any degree of DR and no prior treatment

Urine sample OTHER

Urine sampling for aqueous metabolomics

Also known as: Urine sample for metabolomics

Group 1 - No diabetic retinopathy or maculopathy; Group 2 - Mild preproliferative DR; Group 3 - Moderate Pre-proliferative DR; Group 4 - Severe pre-proliferative DR; Group 5 - Proliferative DR; Group 6 - DMO with any degree of DR and no prior treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Diagnosis of type 2 diabetes mellitus
• Male or female aged 18 - 80 inclusive

You may not qualify if:

• 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

Sponsors & Collaborators

• Hywel Dda Health Board: lead
• University of Aberdeen: collaborator

Study Sites (1)

Prince Philip Hospital

Llanelli, Wales, SA14 8QF, United Kingdom

RECRUITING

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Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood plasma and urine

MeSH Terms

Conditions

Diabetic Retinopathy

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Francis WB Sanders, MB BChir PhD FRCOphth

  Hywel Dda University Health Board

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francis WB Sanders, MB BChir PhD FRCOphth

CONTACT

+447717171199; francis.sanders@wales.nhs.uk

Eirini Skiadaresi

CONTACT

+447427120616; eirini.skiadaresi@wales.nhs.uk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Honorary Research Fellow

Study Record Dates

• First Submitted: March 31, 2025
• First Posted: April 6, 2025
• Study Start: March 31, 2025
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2030
• Last Updated: April 10, 2025

Record last verified: 2025-04

Locations

GB (1)