Dyslipidemia and Diabetic Retinopathy

Completed

• Conditions: Dyslipidemia; Diabetic Retinopathy
• Interventions: Other: 15 subjects with Non Proliferative Diabetic Retinopathy(mild, moderate and severe). 15 subjects with Proliferative Diabetic Retinopathy; Other: Healthy Controls 15 age matched control subjects

• Registration Number: NCT03403283
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-08-07
• Study First Submitted QC: 2018-01-11
• Study First Posted: 2018-01-18
• Primary Completion: 2023-04-30
• Study Completion: 2023-04-30
• Results First Submitted: 2024-03-28
• Status Verified: 2024-05
• Results First Submitted QC: 2024-05-16
• Last Update Submitted: 2024-05-16
• Results First Posted: 2024-05-21
• Last Update Posted: 2024-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Diabetic	15 subjects with Non Proliferative Diabetic Retinopathy(mild, moderate and severe). 15 subjects with Proliferative Diabetic Retinopathy	Diabetics with mild, moderate or severe non proliferative retinopathy and proliferative retinopathy
Controls	Healthy Controls 15 age matched control subjects	Healthy Controls

Primary Outcome Measures

Name	Time	Method
Increase in Acid Sphingomyelinase (ASM) Expression and Activity in Bone Marrow-derived Endothelial Progenitor Cells (EPCs)	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

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States