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

NCT06272565 | Not Yet Recruiting

• 1 other identifier: 2023KYPJ292
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Retinopathy; Diabetic Macular Edema; Anti-vascular Endothelial Growth Factor

Keywords

Diabetic retinopathy; metabolomics; NLPR3; Diabetic Macular edema; Anti-vascular endothelial growth factor

Outcome Measures

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.

  24 weeks

Secondary Outcomes (2)

• Best-corrected visual acuity

  24 weeks

• Central subfield thickness

  24 weeks

Study Arms (4)

CON(Non diabetes control group)

Non diabetes patients undergoing phacoemulsification surgery

NDR(Non diabetes retinopathy diabetes patients)

Non DR diabetes patients undergoing phacoemulsification surgery

NPDR (non proliferative diabetes retinopathy)

DR patients with no sign of any neovascularization suggested by fluorescein sodium angiography and receiving intravitreal injection surgery

PDR (proliferative diabetes retinopathy)

DR patients with neovascularization suggested by fluorescein sodium angiography and receiving intravitreal injection surgery

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.
• 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.
• Patients voluntarily signed informed consent.

You may not qualify if:

• 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。
• Patients with active ocular inflammation, high myopia, pregnancy.

Sponsors & Collaborators

• Zhongshan Ophthalmic Center, Sun Yat-sen University: lead

Study Sites (1)

Zhongshan Ophthalmic Center of Sun Yat-sen University

Guangzhou, Guangdong, 510623, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

blood and aqueous humor

MeSH Terms

Conditions

Diabetic Retinopathy

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Hui Chen, PHD

CONTACT

0086-20-87330000; chh5413@126.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2024
• First Posted: February 22, 2024
• Study Start: July 3, 2024
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: July 1, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)