Exploring the Interaction Between Metabolic Disorders and NLPR3 Inflammasome Activation in DR Inflammatory Damage
- Sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen University
- Study ID
- NCT06272565
- Status
- Not Yet Recruiting
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Conditions
- Anti-vascular Endothelial Growth Factor
- Diabetic Macular Edema
- Diabetic Retinopathy
Eligibility Criteria
- Sex
- ALL
- Age
- 40 Years - 90 Years
- Healthy Volunteers
- Not accepted
Study Details
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.
Key Dates
- First listed
- Feb 22, 2024
- Start date
- Jul 3, 2024
- Status verified
- Jun 2024
- Primary completion
- Dec 30, 2026
- Completion
- Dec 30, 2026
Study Design
- Enrollment
- 240 participants (estimated)
Arms
- Arm: CON(Non diabetes control group)Non diabetes patients undergoing phacoemulsification surgery
- Arm: NDR(Non diabetes retinopathy diabetes patients)Non DR diabetes patients undergoing phacoemulsification surgery
- Arm: NPDR (non proliferative diabetes retinopathy)DR patients with no sign of any neovascularization suggested by fluorescein sodium angiography and receiving intravitreal injection surgery
- Arm: PDR (proliferative diabetes retinopathy)DR patients with neovascularization suggested by fluorescein sodium angiography and receiving intravitreal injection surgery
Primary Outcome Measure
Untargeted metabolomics for metabolic profile using UHPLC/MS [ Time Frame: 24 weeks ]
Central Contacts
- Hui Chen, PHD0086-20-87330000
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