D&D: Dyslipidemia and Diabetic Retinopathy

• Sponsor: University of Alabama at Birmingham (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03403283
• Collaborator: National Eye Institute (NEI) (NIH)
• Enrollment: 45
• Location: 1
• Duration (Months): 120
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Retinopathy; Dyslipidemia	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

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 Design

• Study Type: Observational
• Anticipated Enrollment: 45 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Dyslipidemia and Diabetic Retinopathy
• Study Start Date: Jan 1, 2014
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Group 1 Diabetic	Other: 15 subjects with Non Proliferative Diabetic Retinopathy(mild, moderate and severe). 15 subjects with Proliferative Diabetic Retinopathy; Other Names: NPDR - Non Proliferative Diabetic Retinopathy PDR -Proliferative Diabetic Retinopathy
Group 2 Healthy Controls	Other: Healthy Controls 15 age matched control subjects

Outcome Measures

Primary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35294

Sponsors and Collaborators

• University of Alabama at Birmingham
• National Eye Institute (NEI)

Investigators

• Principal Investigator: Maria B Grant, MD, University of Alabama at Birmingham

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Maria Grant, Principal Investigator, University of Alabama at Birmingham
• ClinicalTrials.gov Identifier: NCT03403283
• Other Study ID Numbers: 300000188; 5R01EY016077
• First Posted: Jan 18, 2018
• Last Update Posted: Aug 15, 2022
• Last Verified: Aug 1, 2022

• Additional relevant MeSH terms: Retinal Diseases; Diabetic Retinopathy; Dyslipidemias

Study Results

No Results Posted as of Aug 15, 2022