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

Not yet recruiting

• Conditions: Anti-vascular Endothelial Growth Factor; Diabetic Retinopathy; Diabetic Macular Edema

• Registration Number: NCT06272565
• Lead Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-01
• Study First Submitted QC: 2024-02-20
• Study First Posted: 2024-02-22
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-27
• Last Update Posted: 2024-07-01
• Study Start: 2024-07-03
• Primary Completion: 2026-12-30
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

1. Patients > 40 years old.
2. CON (non diabetes control group)：patients undergoing phacoemulsification surgery.
3. NDR (non diabetes retinopathy diabetes patients): patients with diabetes history and undergoing phacoemulsification surgery.
4. 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.
5. PDR (proliferative diabetes retinopathy): patients with a history of diabetes, fundus neovascular lesions shown by fundus fluorescein angiography, and did not receive invasive ophthalmic treatment within 3 months.
6. Patients voluntarily signed informed consent.

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Exclusion Criteria

1. CON (non diabetes control group)：patients with a history of other ophthalmic operations.
2. NDR (non diabetes retinopathy diabetes patients): patients with fundus changes of diabetes retinopathy or other ophthalmic surgery history.
3. NPDR (non proliferative diabetes retinopathy): patients with fundus neovascular lesions shown by fundus fluorescein angiography.
4. PDR (proliferative diabetes retinopathy):patients undergoing vitrectomy。
5. Patients with active ocular inflammation, high myopia, pregnancy.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Untargeted metabolomics for metabolic profile using UHPLC/MS	24 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Central subfield thickness	24 weeks	Central subfield thickness at baseline and 24 weeks follow-up
Best-corrected visual acuity	24 weeks	Best-corrected visual acuity at baseline and 24 weeks follow-up

Trial Locations

Locations (1)

Zhongshan Ophthalmic Center of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China