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Blood-retinal Barrier Imaging and Neuropsychiatric Sequela in Type 2 Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT01107132
Recruitment Status : Unknown
Verified April 2010 by Soroka University Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : April 20, 2010
Last Update Posted : April 20, 2010
Sponsor:
Information provided by:
Soroka University Medical Center

Brief Summary:

In Type 2 Diabetes mellitus patients we will:

  1. quantify vasculopathy and blood-retinal barrier (BRB) leakage
  2. measure blood-brain barrier (BBB) permeability and neuroanatomical changes
  3. correlate BRB pathology with BBB breakdown, inflammatory markers and neuropsychiatric sequela

Condition or disease
Type 2 Diabetes Mellitus Non-Proliferative Diabetic Retinopathy Diabetic Macular Edema

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Official Title: Blood-retinal Barrier Imaging in Type 2 Diabetes Mellitus: a Window for Blood-brain Barrier Breakdown and Neuropsychiatric Sequela
Study Start Date : May 2010

Resource links provided by the National Library of Medicine


Group/Cohort
Diabetic Retinopathy
T2DM Patient suffering from Non-Proliferative Diabetic Retinopathy (NPDR), Proliferative Diabetic Retinopathy (PDR) and Diabetic Macular Edema (DME)



Biospecimen Retention:   Samples Without DNA

• Fluorescein Angiography

  1. Investigation and documentation of the retinal and choroidal vascular systems integrity by intravenous administration of sodium fluorescein
  2. FA images are recorded in a central database with restricted accesses and are routinely analyzed by the eye specialist


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Type 2 Diabetes Mellitus Patient suffering from Non-Proliferative Diabetic Retinopathy (NPDR), Proliferative Diabetic Retinopathy (PDR) and Diabetic Macular Edema
Criteria

Inclusion criteria:

  1. T2DM Patient suffering from Non-Proliferative Diabetic Retinopathy (NPDR), Proliferative Diabetic Retinopathy (PDR) and Diabetic Macular Edema (DME) who are in the clinical database of the ophthalmologic department , above 18 years old at the time of diagnosis and underwent FA examination in the past three years
  2. Patients which their medical records are available via a computerized data base

Control group:

  1. T2DM patients who are in the clinical database of the ophthalmologic department
  2. Above 18 years old at the time of diagnosis
  3. Underwent FA examination in the past three years and their examination was interpreted as "normal", i.e. without suspected 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): NCT01107132


Contacts
Contact: Hadar Shalev, M.D 972506996696 shalev@bgu.ac.il

Locations
Israel
Soroka University Medical Center Not yet recruiting
Beer-Sheva, Israel
Contact: Hadar Shalev, M.D       shalev@bgu.ac.il   
Principal Investigator: Hadar Shalev, M.D         
Sponsors and Collaborators
Soroka University Medical Center
Investigators
Principal Investigator: Hadar Shalev, M.D Soroka University Medical Center

Responsible Party: Hadar Shalev, M.D, Soroka University Medical Center
ClinicalTrials.gov Identifier: NCT01107132     History of Changes
Other Study ID Numbers: SOR495710ctil
First Posted: April 20, 2010    Key Record Dates
Last Update Posted: April 20, 2010
Last Verified: April 2010

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Macular Edema
Diabetic Retinopathy
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications