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Completed

NCT Number: NCT03403283

Dyslipidemia and Diabetic Retinopathy

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other

Other names: NPDR - Non Proliferative Diabetic Retinopathy, PDR -Proliferative Diabetic Retinopathy

Healthy Controls 15 age matched control subjects

Other

Primary outcomes

  1. Increase in Acid Sphingomyelinase (ASM) Expression and Activity in Bone Marrow-derived Endothelial Progenitor Cells (EPCs)

    Time frame: 3 years

    Peripheral blood of 150 cc, about 8-10 tablespoons will be collected from vein in the arm of both diabetic and control subjects.ASM activity was measured on a scale of 0-0.6. 0.6 is worse with units being nM/hr

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • National Eye Institute (NEI)

Registry information

Acronym: D&D

Important dates

Study start
2014
Primary completion
2023
Study completion
2023
First posted
Jan 18, 2018
Registry last updated
May 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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