Diabetic RetinopathyNCT06188013
Proteomic Study of Plasma Exosomes in Patients With Diabetic Retinopathy
An observational study of Diabetic Retinopathy, run by Xuanwu Hospital, Beijing.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetic Retinopathy
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 2 Jan 2024to 30 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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)；
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: December,2023-June,2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study start2 Jan 2024 (estimated)
- Primary completion31 Mar 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic RetinopathyStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06188013
- Sponsor's protocol ID
- wuhang2317
- Status last verified
- Nov 2023
- First submitted
- 11 Dec 2023
- Last updated
- 3 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proteomic Study of Plasma Exosomes in Patients With Diabetic Retinopathy
- ClinicalTrials.gov ID
- NCT06188013
- Acronym / sponsor ID
- wuhang2317
- Conditions
- Diabetic Retinopathy
- Keywords
- plasma, exosome, Diabetic Retinopathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 2 Jan 2024 (estimated)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 3 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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)；
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
differential proteins of exosomes
Time frame: December,2023-June,2024
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Retinopathy, run by Xuanwu Hospital, Beijing.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hang Wu, Master (+86-13911993866, wuhang2317@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
differential proteins of exosomes (time frame: December,2023-June,2024). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2024.