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NCT01107132 Clinical Trial

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

Type 2 Diabetes Mellitus Clinical Trial

Official title:
Blood-retinal Barrier Imaging in Type 2 Diabetes Mellitus: a Window for Blood-brain Barrier Breakdown and Neuropsychiatric Sequela

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT01107132
Other study ID # SOR495710ctil
Secondary ID
Status Not yet recruiting
Phase N/A
First received April 18, 2010
Last updated April 19, 2010
Start date May 2010

Study information
Verified date April 2010
Source Soroka University Medical Center
Contact Hadar Shalev, M.D
Phone 972506996696
Email shalev@bgu.ac.il
Is FDA regulated No
Health authority Israel: Ethics Commission
Study type Observational

Clinical Trial 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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 100
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

Locations
Country Name City State
Israel Soroka University Medical Center Beer-Sheva

Sponsors (1)
Lead Sponsor Collaborator
Soroka University Medical Center

Country where clinical trial is conducted

Israel, 

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