Monocyte Chemoattractant Protein-1 2518A/G Polymorphism | NCT02077127

Studies
Monocyte Chemoattractant Protein-1 2518A/G Polymorphism

NCT02077127

Sponsor

Harbin Medical University

Status

Completed

Last Update Posted

Mar 5, 2014Estimated

Enrollment

1,043Actual

Phase

Not provided

Conditions

Diabetic Retinopathy

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2011

Primary Completion Date

Feb 2013Actual

Completion Date

Apr 2013Actual

First Submitted Date

Jun 10, 2013

First Submission Date that Met QC Criteria

Feb 28, 2014

First Posted Date

Mar 4, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 3, 2014

Last Update Posted Date

Mar 5, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

1,043Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Genetic association	age at diagnosis of diabetes ≥30 years and a known duration of diabetes of ≥5 years.	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Type 2 diabetic retinopathy
age at diagnosis ≥30 years and a known duration of diabetes of ≥5 years.

Exclusion Criteria:

eyeball atrophy
epimacular membrane
age-related macular degeneration (ARMD)
intravitreal injection medicine
vitreous hemorrhage

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

41 Years

Maximum Age

68 Years

Standard Ages

AdultOlder Adult

Study Population

residents of a certain province

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ping Liu, Doctor	First Affiliated Hospital of Harbin Medical University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Harbin Medical University		Harbin	Heilongjiang	150001	China

Condition Browse Module

MeSH Terms

ID	Term
D003930	Diabetic Retinopathy

Ancestor Terms

ID	Term
D012164	Retinal Diseases
D005128	Eye Diseases
D003925	Diabetic Angiopathies
D014652	Vascular Diseases

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Browse Branches

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