Dyslipidemia and Diabetic Retinopathy

Diabetic Retinopathy Clinical Trial

— D&D  

Official title:

Dyslipidemia and Diabetic Retinopathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03403283
• Other study ID #: 300000188
• Secondary ID: 5R01EY016077
• Status: Completed
• Start date: January 2014
• Est. completion date: April 30, 2023

Study information

• Verified date: May 2024
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: April 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Dyslipidemia
• Dyslipidemias
• Retinal Diseases

Intervention

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

• Healthy Controls 15 age matched control subjects

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	National Eye Institute (NEI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increase in Acid Sphingomyelinase (ASM) Expression and Activity in Bone Marrow-derived Endothelial Progenitor Cells (EPCs)	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	3 years