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Dyslipidemia and Diabetic Retinopathy (D&D)

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ClinicalTrials.gov Identifier: NCT03403283
Recruitment Status : Recruiting
First Posted : January 18, 2018
Last Update Posted : February 15, 2019
Sponsor:
Collaborator:
National Eye Institute (NEI)
Information provided by (Responsible Party):
Maria Grant, 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.

Condition or disease Intervention/treatment
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.

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Study Type : Observational
Estimated Enrollment : 45 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Dyslipidemia and Diabetic Retinopathy
Study Start Date : January 2014
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


Group/Cohort 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



Primary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Ophthalmology and Primary Care Clinics
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03403283


Contacts
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Contact: Jennifer Moorer 205 325 8674 jmoorer@uabmc.edu

Locations
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United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Maris B Grant, MD, PhD    317-274-2628    mabgrant@iupui.edu   
Contact: Jennifer Moorer    205 3258674    jmoorer@uabmc.edu   
Principal Investigator: Maria B Grant, MD, PhD.         
Sponsors and Collaborators
University of Alabama at Birmingham
National Eye Institute (NEI)
Investigators
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Principal Investigator: Maria B Grant, MD University of Alabama at Birmingham

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Responsible Party: Maria Grant, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03403283     History of Changes
Other Study ID Numbers: 300000188
5R01EY016077 ( U.S. NIH Grant/Contract )
First Posted: January 18, 2018    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019

Additional relevant MeSH terms:
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Retinal Diseases
Dyslipidemias
Diabetic Retinopathy
Eye Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases