Diabetic RetinopathyMCP-1NCT02077127
Monocyte Chemoattractant Protein-1 2518A/G Polymorphism
An observational study of Diabetic Retinopathy, run by Harbin Medical University at 1 site in China.
Trial summary
The pathogenesis of proliferative diabetic retinopathy (PDR) remains poorly understood. Recent studies have implicated that monocyte chemoattractant protein-1 (MCP-1) is associated with diabetic microvascular or macrovascular complications. Read more about this study
- Who is it for?
- Ages 41 to 68 years
- Conditions the study is for
- Diabetic Retinopathy
- How many people
- 1,043 participants
- Where
- 1 siteChina
- Study dates
- Sep 2011to Apr 2013
- 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 41 to 68 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: residents of a certain province
Who may be able to join
- Type 2 diabetic retinopathy
- age at diagnosis ≥30 years and a known duration of diabetes of ≥5 years.
Who cannot join
- eyeball atrophy
- epimacular membrane
- age-related macular degeneration (ARMD)
- intravitreal injection medicine
- vitreous hemorrhage
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association of Monocyte Chemoattractant Protein-1 (MCP-1)2518A/G Polymorphism With Proliferative Diabetic Retinopathy in Northern Chinese Type 2 Diabetes
The pathogenesis of proliferative diabetic retinopathy (PDR) remains poorly understood. Recent studies have implicated that monocyte chemoattractant protein-1 (MCP-1) is associated with diabetic microvascular or macrovascular complications. However, the relationship between SNP polymorphism c.2518A/G in the MCP-1 gene with diabetic retinopathy remains controversial. In the present study, we evaluated the association of a single nucleotide polymorphism (SNP) in the MCP-1 gene with diabetic retinopathy (DR) and diabetic macular edema (DME) in Chinese population from Southern China with type 2 diabetes.
Read the detailed description
The association between polymorphism of MCP-1 c.2518A/G and DR had been reported in Japan and Korea, but their opinion were inconsistent. However there is no report in China so far. This study was designed to clarify the relationship of polymorphism of MCP-1 c.2518A/G with type 2 diabetes with or without DR. The relationship between MCP-1 c.2518A/G and different stage of DR has also been studied.This article proved that the MCP-1 c.2518G/G genotype is a susceptibility gene for DR in Chinese type 2 diabetic patients, especially the High-risk PDR. There is no association with DME and c.2518G/G.
- Conditions
- Diabetic Retinopathy
- Medical subject headings
- Diabetic Retinopathy
What is being measured
The primary outcome is the main question the study is designed to answer.
Genetic association
age at diagnosis of diabetes ≥30 years and a known duration of diabetes of ≥5 years.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2014 (estimated)
- Study startSep 2011
- Primary completionFeb 2013
- Study completionApr 2013
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.
- 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
- Cross-sectional
- Enrolment
- 1,043 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harbin Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Dong, Harbin Medical University
- Investigators
- Ping Liu, Doctor, Study chair, First Affiliated Hospital of Harbin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02077127
- Sponsor's protocol ID
- dongli
- Acronym
- MCP-1
- Status last verified
- Mar 2014
- First submitted
- 10 Jun 2013
- Last updated
- 5 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Monocyte Chemoattractant Protein-1 (MCP-1)2518A/G Polymorphism With Proliferative Diabetic Retinopathy in Northern Chinese Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT02077127
- Acronym / sponsor ID
- MCP-1 / dongli
- Conditions
- Diabetic Retinopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,043 participants (actual)
- Lead sponsor
- Harbin Medical UniversityUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Feb 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 4 Mar 2014 (estimated)
- 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.
The pathogenesis of proliferative diabetic retinopathy (PDR) remains poorly understood. Recent studies have implicated that monocyte chemoattractant protein-1 (MCP-1) is associated with diabetic microvascular or macrovascular complications. However, the relationship between SNP polymorphism c.2518A/G in the MCP-1 gene with diabetic retinopathy remains controversial. In the present study, we evaluated the association of a single nucleotide polymorphism (SNP) in the MCP-1 gene with diabetic retinopathy (DR) and diabetic macular edema (DME) in Chinese population from Southern China with type 2 diabetes.
Detailed description
The association between polymorphism of MCP-1 c.2518A/G and DR had been reported in Japan and Korea, but their opinion were inconsistent. However there is no report in China so far. This study was designed to clarify the relationship of polymorphism of MCP-1 c.2518A/G with type 2 diabetes with or without DR. The relationship between MCP-1 c.2518A/G and different stage of DR has also been studied.This article proved that the MCP-1 c.2518G/G genotype is a susceptibility gene for DR in Chinese type 2 diabetic patients, especially the High-risk PDR. There is no association with DME and c.2518G/G.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 41 to 68 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- residents of a certain province
Key inclusion criteria (2 listed)
- Type 2 diabetic retinopathy
- age at diagnosis ≥30 years and a known duration of diabetes of ≥5 years.
Key exclusion criteria (5 listed)
- eyeball atrophy
- epimacular membrane
- age-related macular degeneration (ARMD)
- intravitreal injection medicine
- vitreous hemorrhage
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
Genetic association
Time frame: 1 year
age at diagnosis of diabetes ≥30 years and a known duration of diabetes of ≥5 years.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2014.
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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.
Ping Liu, Doctor study chair
First Affiliated Hospital of Harbin Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Retinopathy, run by Harbin Medical University at 1 site in China.
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 5 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: finished, as of the sponsor's last update on 5 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genetic association (time frame: 1 year). 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 5 Mar 2014; AzTrials last refreshed its copy on 30 Oct 2026.