Proteomic Study of Plasma Exosomes in Patients With Diabetic Retinopathy

NCT06188013 | Unknown

• 1 other identifier: wuhang2317
• Study Type: observational
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

Objective: Explore the biomarkers related to proliferative diabetic retinopathy by analyzing the protein expression profile changes of plasma exosomes in patients with difference phases of diabetic retinopathy, and investigate potential molecular mechanisms and therapeutic targets. Methods: Enrich exosomes from plasma by column extraction method. NTA, WB and TEM were used to characterize the obtained exosomes, and exosome proteinomics was performed by chromatography⁃mass spectrometry. Corhorts: The study was divided into four groups: a healthy control group, a diabetic without diabetic retinopathy group, a non-proliferative diabetic retinopathy group, and a proliferative diabetic retinopathy group, with 6 cases in each group.

Conditions

Diabetic Retinopathy

Keywords

plasma; exosome; Diabetic Retinopathy

Outcome Measures

Primary Outcomes (1)

• differential proteins of exosomes

  Exosomes were extracted and isolated from plasma, proteomics analysis of proteins in exosomes was performed to compare the number of types of changes in exosomal proteins of the four groups and to identify proteins that were up-regulated and/or down-regulated, and the relationship between the proteins and diabetic retinopathy was then analysed to look for possible mechanisms and therapeutic targets for diabetic retinopathy.

  December,2023-June,2024

Study Arms (4)

proliferative diabetic retinopathy

Age ≥18 years old；patients diagnosed with PDR by FFA

non-proliferative diabetic retinopathy

Age ≥18 years old；patients diagnosed with NPDR by FFA

diabetes mellitus without retinopathy

Age ≥18 years old；patients diagnosed with Diabetes Mellitus；patients weren't diagnosed with diabetic retinopathy

health control

Age ≥18 years old；patients weren't diagnosed with Diabetes Mellitus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Plasma exosomal proteomics studies in patients with diabetic retinopathy should include healthy volunteers without diabetes mellitus and elderly cataract patients without diabetes mellitus; patients with systemic diseases such as cancer, immune disorders, infectious diseases, and hematological disorders, as well as patients suffering from cerebral infarcts, cardiac infarcts, and other cardiovascular diseases, are not eligible for enrollment.

You may qualify if:

• Healthy volunteers without diabetes/ Senile cataract patients without diabetes；
• Patients with diabetes who are diagnosed without DR, NPDR, and PDR by mydriatic fundus photography (or FFA)；

You may not qualify if:

• Patients with systemic diseases such as cancer, immune diseases, infectious diseases, and blood diseases；
• Patients with cerebral infarction, myocardial infarction and other cardiovascular and cerebrovascular diseases

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

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

Hang Wu, Master

CONTACT

+86-13911993866; wuhang2317@163.com

Zhen Li, Doctor

CONTACT

+86-13581646689; zhenli_xwyy@163.com

Study Design

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

Study Record Dates

• First Submitted: December 11, 2023
• First Posted: January 3, 2024
• Study Start: January 2, 2024
• Primary Completion: March 31, 2024
• Study Completion: June 30, 2024
• Last Updated: January 3, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share