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Blood Factors and Diabetic Retinopathy

Primary Purpose

Diabetic Retinopathy

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
National Eye Institute (NEI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Diabetic Retinopathy focused on measuring Types 1 & 2 Diabetes, Cell Adhesion Molecules, Chemokines, Vascular Endothelial Growth Factor, Cross-Sectional, Serum Levels, Diabetic Retinopathy

Eligibility Criteria

10 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

VOLUNTEER INCLUSION CRITERIA: Volunteers will be able to enroll if they: Have the ability to understand and sign an informed consent. Are able and willing to give a blood sample. Are healthy as determined by study Investigator. Have no chronic diseases. Do not exhibit any clinical indications of diabetes. PARTICIPANT INCLUSION CRITERIA: Participants will be able to enroll if they: Have the ability to understand and sign an informed consent. Are able and willing to give a blood sample. Have a clinical diagnosis of diabetes based on any one of the following criteria: Documented history of plasma glucose value greater than or equal to 210 mg/dl on three different occasions. Fasting blood sugar greater than or equal to 150 mg/dl on three different occasions. Documented history of ketoacidosis. Insulin dependency. Documented history of abnormal glucose tolerance test. EXCLUSION CRITERIA: Neither volunteers nor participants will be eligible if they: Are under the age of 10. Have severe systemic disease(s) that compromise our ability to obtain an adequate examination. Have any of the following ocular characteristics or conditions in both eyes: Opacities of the ocular media, limitations or pupillary dilation or any other problems sufficient to preclude good, quality stereo fundus photographs. Ocular disease which confounds assessment of diabetic retinopathy such as advanced age-related macular degeneration, central serous choroidopathy, optic atrophy, retinal vein occlusion, active uveitis, significant explained or unexplained visual field loss, or any other type of retinopathy or retinal degeneration. Chronic requirement for any ocular medication for other diseases, such as glaucoma.

Sites / Locations

  • National Institutes of Health Clinical Center, 9000 Rockville Pike

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 26, 2000
Last Updated
June 30, 2017
Sponsor
National Eye Institute (NEI)
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1. Study Identification

Unique Protocol Identification Number
NCT00005761
Brief Title
Blood Factors and Diabetic Retinopathy
Official Title
Study of Association of Serum Factors With Diabetic Retinopathy
Study Type
Observational

2. Study Status

Record Verification Date
December 7, 2010
Overall Recruitment Status
Completed
Study Start Date
May 23, 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 7, 2010 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Eye Institute (NEI)

4. Oversight

5. Study Description

Brief Summary
This study will determine whether certain factors in the blood are associated with the severity of diabetic retinopathy. Patients age 10 years and older with diabetes mellitus and diabetic retinopathy may be eligible for this study. Those enrolled will represent a range of diabetic retinopathy from minimal to severe. Participants will undergo the following procedures: medical history thorough eye examination photographs of the eye blood tests to measure blood lipids (cholesterol and triglycerides) and serum creatinine (for kidney function) blood tests to measure levels of blood factors (cell adhesion molecules, chemokines and vascular endothelial growth factor) that may be related to the progression of diabetic retinopathy blood pressure measurement urinalysis This study may lead to a better understanding of how diabetic retinopathy develops and progresses.
Detailed Description
Participants with a range of severity of diabetic retinopathy and healthy volunteers will be evaluated once for serum levels of cell adhesion molecules, chemokines and vascular endothelial growth factor. This study may lead to a better understanding of the pathogenesis of diabetic retinopathy and the identifying of possible targets for treatment. All study participants will undergo an ocular exam and ophthalmic photography. Blood is drawn for the analysis of these serum factors.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Retinopathy
Keywords
Types 1 & 2 Diabetes, Cell Adhesion Molecules, Chemokines, Vascular Endothelial Growth Factor, Cross-Sectional, Serum Levels, Diabetic Retinopathy

7. Study Design

Enrollment
173 (Actual)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
VOLUNTEER INCLUSION CRITERIA: Volunteers will be able to enroll if they: Have the ability to understand and sign an informed consent. Are able and willing to give a blood sample. Are healthy as determined by study Investigator. Have no chronic diseases. Do not exhibit any clinical indications of diabetes. PARTICIPANT INCLUSION CRITERIA: Participants will be able to enroll if they: Have the ability to understand and sign an informed consent. Are able and willing to give a blood sample. Have a clinical diagnosis of diabetes based on any one of the following criteria: Documented history of plasma glucose value greater than or equal to 210 mg/dl on three different occasions. Fasting blood sugar greater than or equal to 150 mg/dl on three different occasions. Documented history of ketoacidosis. Insulin dependency. Documented history of abnormal glucose tolerance test. EXCLUSION CRITERIA: Neither volunteers nor participants will be eligible if they: Are under the age of 10. Have severe systemic disease(s) that compromise our ability to obtain an adequate examination. Have any of the following ocular characteristics or conditions in both eyes: Opacities of the ocular media, limitations or pupillary dilation or any other problems sufficient to preclude good, quality stereo fundus photographs. Ocular disease which confounds assessment of diabetic retinopathy such as advanced age-related macular degeneration, central serous choroidopathy, optic atrophy, retinal vein occlusion, active uveitis, significant explained or unexplained visual field loss, or any other type of retinopathy or retinal degeneration. Chronic requirement for any ocular medication for other diseases, such as glaucoma.
Facility Information:
Facility Name
National Institutes of Health Clinical Center, 9000 Rockville Pike
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
1526332
Citation
Winocour PD. Platelet abnormalities in diabetes mellitus. Diabetes. 1992 Oct;41 Suppl 2:26-31. doi: 10.2337/diab.41.2.s26.
Results Reference
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PubMed Identifier
8115982
Citation
Lupu C, Calb M, Ionescu M, Lupu F. Enhanced prothrombin and intrinsic factor X activation on blood platelets from diabetic patients. Thromb Haemost. 1993 Oct 18;70(4):579-83.
Results Reference
background
PubMed Identifier
3546072
Citation
Jaffe EA. Cell biology of endothelial cells. Hum Pathol. 1987 Mar;18(3):234-9. doi: 10.1016/s0046-8177(87)80005-9.
Results Reference
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Blood Factors and Diabetic Retinopathy

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