NCT02077127

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,043

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2013

Completed
9 months until next milestone

First Posted

Study publicly available on registry

March 4, 2014

Completed
Last Updated

March 5, 2014

Status Verified

March 1, 2014

Enrollment Period

1.4 years

First QC Date

June 10, 2013

Last Update Submit

March 3, 2014

Conditions

Diabetic Retinopathy

Outcome Measures

Primary Outcomes (1)

  • Genetic association

    age at diagnosis of diabetes ≥30 years and a known duration of diabetes of ≥5 years.

    1 year

Eligibility Criteria

Age41 Years - 68 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

residents of a certain province

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harbin Medical University

Harbin, Heilongjiang, 150001, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood had been stored in -80℃.

MeSH Terms

Conditions

Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Study Officials

  • Ping Liu, Doctor

    First Affiliated Hospital of Harbin Medical University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Li Dong

Study Record Dates

First Submitted

June 10, 2013

First Posted

March 4, 2014

Study Start

September 1, 2011

Primary Completion

February 1, 2013

Study Completion

April 1, 2013

Last Updated

March 5, 2014

Record last verified: 2014-03

Locations

CN(1)