Proteomic Study of Plasma Exosomes in Patients With Diabetic Retinopathy

Diabetic Retinopathy Clinical Trial

Official title:

Proteomic Study of Plasma Exosomes in Patients With Diabetic Retinopathy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06188013
• Other study ID #: wuhang2317
• Status: Not yet recruiting
• Start date: January 2, 2024
• Est. completion date: June 30, 2024

Study information

• Verified date: November 2023
• Source: Xuanwu Hospital, Beijing
• Contact: Hang Wu, Master
• Phone: +86-13911993866
• Email: wuhang2317[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: June 30, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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);

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Retinal Diseases

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Xuanwu Hospital, Beijing

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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