Exploring the Interaction Between Metabolic Disorders and NLPR3 Inflammasome Activation in DR Inflammatory Damage

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40-90
SponsorZhongshan Ophthalmic Center, Sun Yat-sen University

About this trial

Diabetic retinopathy (DR) is one of the most serious microvascular complications of diabetes. Early diagnosis and treatment of diabetes is the key to prevent visual impairment in DR patients. This study aims to use a non-targeted metabolomics detection technique combined with ultra-high performance liquid chromatography time-of-flight mass spectrometry to analyze the metabolomics profile in aqueous humor sample of DR patents, and further explore the mechanism of the relationship between differential metabolites and their metabolic pathways with NLRP3 activation in DR inflammatory damage. DR patients with macular edema will receive anti-vascular endothelial growth factor (anti-VEGF) treatment; these patients will be divided into two groups: responders group and non-responders group.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients > 40 years old.

CON (non diabetes control group):patients undergoing phacoemulsification surgery.

NDR (non diabetes retinopathy diabetes patients): patients with diabetes history and undergoing phacoemulsification surgery.

NPDR (non proliferative diabetes retinopathy): patients with history of diabetes, fundus microangiopathy shown by fundus fluorescein angiography, including microangioma, hard exudation, wadding exudation and other non proliferative diabetes retinopathy signs, and did not receive invasive ophthalmic treatment within 3 months.

Disqualifiers

CON (non diabetes control group):patients with a history of other ophthalmic operations.

NDR (non diabetes retinopathy diabetes patients): patients with fundus changes of diabetes retinopathy or other ophthalmic surgery history.

NPDR (non proliferative diabetes retinopathy): patients with fundus neovascular lesions shown by fundus fluorescein angiography.

PDR (proliferative diabetes retinopathy):patients undergoing vitrectomy。

Trial population

1. CON (non diabetes control group):Non diabetes patients undergoing phacoemulsification surgery. 2. NDR (non diabetes retinopathy diabetes patients): Non DR diabetes patients undergoing phacoemulsification surgery. 3. NPDR (non proliferative diabetes retinopathy): DR patients with no sign of any neovascularization suggested by fluorescein sodium angiography and receiving intravitreal injection surgery. 4. PDR (proliferative diabetes retinopathy): DR patients with neovascularization suggested by fluorescein sodium angiography and receiving intravitreal injection surgery.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

240 Participants
are grouped into 4 trial groups
Group A: CON(Non diabetes control group)
Group B: NDR(Non diabetes retinopathy diabetes patients)
Group C: NPDR (non proliferative diabetes retinopathy)
Group D: PDR (proliferative diabetes retinopathy)

Trial outcomes

Primary outcomes

1

Untargeted metabolomics for metabolic profile using UHPLC/MS

Aqueous humor samples in DR patients will be analysed to putatively identify metabolic profile by comparison with control samples using ultra-high performance liquid chromatography-high resolution mass spectrometer (UHPLC/MS). UHPLC/MS analysis allows the simultaneous high-resolution measurement of a broad range of metabolites, hence the untargeted nature of the analysis. For the UHPLC/MS results, perform normalization, standardization, and log transformation, then compare the metabolite differences between groups. Multivariate statistical analysis and Partial least squares discriminant analysis included in the mass spectrometry software will be used to analyse UHPLC/MS results to identify metabolites that best discriminate between DR and control conditions. The evaluation of significant metabolite results is based on: P-value and Fold change.

Time frame
24 weeks

Secondary outcomes

1

Best-corrected visual acuity

Best-corrected visual acuity at baseline and 24 weeks follow-up

Time frame
24 weeks
2

Central subfield thickness

Central subfield thickness at baseline and 24 weeks follow-up

Time frame
24 weeks

Other outcomes

Sponsors and contacts

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