Blood Factors and Diabetic Retinopathy

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00005761
First received: May 26, 2000
Last updated: December 8, 2010
Last verified: December 2010
  Purpose

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.


Condition
Diabetic Retinopathy

Study Type: Observational
Official Title: Study of Association of Serum Factors With Diabetic Retinopathy

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Enrollment: 173
Study Start Date: May 2000
Estimated Study Completion Date: December 2010
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.

  Eligibility

Ages Eligible for Study:   10 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005761

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00005761     History of Changes
Other Study ID Numbers: 000135, 00-EI-0135
Study First Received: May 26, 2000
Last Updated: December 8, 2010
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Types 1 & 2 Diabetes
Cell Adhesion Molecules
Chemokines
Vascular Endothelial Growth Factor
Cross-Sectional
Serum Levels
Diabetic Retinopathy

Additional relevant MeSH terms:
Diabetic Retinopathy
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 20, 2014