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Blood Factors and Diabetic Retinopathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00005761
Recruitment Status : Completed
First Posted : May 29, 2000
Last Update Posted : July 2, 2017
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)

Tracking Information
First Submitted Date May 26, 2000
First Posted Date May 29, 2000
Last Update Posted Date July 2, 2017
Study Start Date May 23, 2000
Primary Completion Date Not Provided
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00005761 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Blood Factors and Diabetic Retinopathy
Official Title Study of Association of Serum Factors With Diabetic Retinopathy
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.
Study Type Observational
Study Design Not Provided
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
Condition Diabetic Retinopathy
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 8, 2010)
173
Original Enrollment
 (submitted: June 23, 2005)
175
Study Completion Date December 7, 2010
Primary Completion Date Not Provided
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:

    1. Documented history of plasma glucose value greater than or equal to 210 mg/dl on three different occasions.
    2. Fasting blood sugar greater than or equal to 150 mg/dl on three different occasions.
    3. Documented history of ketoacidosis.
    4. Insulin dependency.
    5. 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:

    1. Opacities of the ocular media, limitations or pupillary dilation or any other problems sufficient to preclude good, quality stereo fundus photographs.
    2. 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.
    3. Chronic requirement for any ocular medication for other diseases, such as glaucoma.
Sex/Gender
Sexes Eligible for Study: All
Ages 10 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00005761
Other Study ID Numbers 000135
00-EI-0135
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Not Provided
Study Sponsor National Eye Institute (NEI)
Collaborators Not Provided
Investigators Not Provided
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date December 7, 2010