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

Diabetic Retinopathy Clinical Trial

— DR  

Official title:

An Approach of Exploring the Mechanism of the Interaction Between Metabolic Disorders and NLPR3 Inflammasome Activation in DR Inflammatory Damage Based on Metabolomics Methods

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06272565
• Other study ID #: 2023KYPJ292
• Status: Not yet recruiting
• Start date: March 1, 2024
• Est. completion date: December 30, 2026

Study information

• Verified date: February 2024
• Source: Zhongshan Ophthalmic Center, Sun Yat-sen University
• Contact: Hui Chen, PHD
• Phone: 0086-20-87330000
• Email: chh5413[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 240
• Est. completion date: December 30, 2026
• Est. primary completion date: December 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 90 Years

Eligibility

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.

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.

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Diabetic Retinopathy
• Macular Edema
• Metabolic Diseases
• Retinal Diseases

Locations

Country	Name	City	State
China	Zhongshan Ophthalmic Center of Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Zhongshan Ophthalmic Center, Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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. 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.	24 weeks
Secondary	Best-corrected visual acuity	Best-corrected visual acuity at baseline and 24 weeks follow-up	24 weeks
Secondary	Central subfield thickness	Central subfield thickness at baseline and 24 weeks follow-up	24 weeks