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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Soroka University Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Soroka University Medical Center
ClinicalTrials.gov Identifier:
NCT01107132
First received: April 18, 2010
Last updated: April 19, 2010
Last verified: April 2010
  Purpose

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
Type 2 Diabetes Mellitus
Non-Proliferative Diabetic Retinopathy
Diabetic Macular Edema

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Blood-retinal Barrier Imaging in Type 2 Diabetes Mellitus: a Window for Blood-brain Barrier Breakdown and Neuropsychiatric Sequela

Resource links provided by NLM:


Further study details as provided by Soroka University Medical Center:

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

Estimated Enrollment: 100
Study Start Date: May 2010
Groups/Cohorts
Diabetic Retinopathy
T2DM Patient suffering from Non-Proliferative Diabetic Retinopathy (NPDR), Proliferative Diabetic Retinopathy (PDR) and Diabetic Macular Edema (DME)

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
  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: 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
  More Information

No publications provided

Responsible Party: Hadar Shalev, M.D, Soroka University Medical Center
ClinicalTrials.gov Identifier: NCT01107132     History of Changes
Other Study ID Numbers: SOR495710ctil
Study First Received: April 18, 2010
Last Updated: April 19, 2010
Health Authority: Israel: Ethics Commission

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

ClinicalTrials.gov processed this record on July 31, 2014