Dyslipidemia and Diabetic Retinopathy

NCT ID: NCT03403283

Last Updated: 2024-05-21

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-31

Study Completion Date

2023-04-30

Brief Summary

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The purpose of this study is to determine if the reparative cells of blood vessels called endothelial progenitor cells(EPC) are defective in people with diabetes.

Detailed Description

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The purpose of this study is to determine if the reparative cells of blood vessels, called endothelial progenitor cells (EPC's) are defective in people with diabetes. Diabetic retinopathy (DR) is an eye disease related to diabetes. It can cause blurred vision and possible bleeding in the blood vessels in the back of the eye (retina). Damage to the cells of the blood vessels from DR can cause vision loss or blindness. Even with current treatments, the quality of life for people with DR is much reduced.

Conditions

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Diabetic Retinopathy Dyslipidemia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Diabetic

Diabetics with mild, moderate or severe non proliferative retinopathy and proliferative retinopathy

15 subjects with Non Proliferative Diabetic Retinopathy(mild, moderate and severe). 15 subjects with Proliferative Diabetic Retinopathy

Intervention Type OTHER

Controls

Healthy Controls

Healthy Controls 15 age matched control subjects

Intervention Type OTHER

Interventions

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15 subjects with Non Proliferative Diabetic Retinopathy(mild, moderate and severe). 15 subjects with Proliferative Diabetic Retinopathy

Intervention Type OTHER

Healthy Controls 15 age matched control subjects

Intervention Type OTHER

Other Intervention Names

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NPDR - Non Proliferative Diabetic Retinopathy PDR -Proliferative Diabetic Retinopathy

Eligibility Criteria

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Inclusion Criteria

* Any man or woman
* Greater than 18 years of age
* Diagnosis of diabetes (applies to the Diabetic Arm only) (N=15 Type 1 and N=15 Type
* The subject must be willing and have the ability to cooperate with the protocol. Children will not be eligible because the investigators need to obtain 150 ml of blood and this is in excess of what can be drawn in children.

Exclusion Criteria

* Female participants must not be pregnant at the time of the blood draw as evident through a dipstick pregnancy test.
* Have retinal abnormalities other than diabetic retinopathy.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Eye Institute (NEI)

NIH

Sponsor Role collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Maria Grant

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maria B Grant, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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5R01EY016077

Identifier Type: NIH

Identifier Source: secondary_id

View Link

300000188

Identifier Type: -

Identifier Source: org_study_id

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