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NCT Number: NCT06272565

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

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.

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Key information

Conditions

Diabetic Retinopathy Anti-vascular Endothelial Growth Factor Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Macular Edema Endocrine System Diseases Eye Diseases Retinal Diseases Vascular Diseases

Age range

40 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhongshan Ophthalmic Center of Sun Yat-sen University

Guangzhou, Guangdong, 510623, China

Location contact

Zhongshan Ophthalmic Center of Sun Yat-sen University

CONTACT

[email protected]

86+13560323773

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Untargeted metabolomics for metabolic profile using UHPLC/MS

    Time frame: 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 outcomes

  1. Best-corrected visual acuity

    Time frame: 24 weeks

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

  2. Central subfield thickness

    Time frame: 24 weeks

    Central subfield thickness at baseline and 24 weeks follow-up

Study contacts

Contact information is provided by the study sponsor or research team.

Hui Chen, PHD

CONTACT

[email protected]

0086-20-87330000

Sponsors and collaborators

Lead sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University

Other

Registry information

Official study 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

Acronym: DR

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 22, 2024
Registry last updated
Jul 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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