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

NCT ID: NCT01107132

Last Updated: 2010-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-05-31

Brief Summary

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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

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Groups

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Diabetic Retinopathy

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Soroka University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Soroka University Medical Center

Principal Investigators

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Hadar Shalev, M.D

Role: PRINCIPAL_INVESTIGATOR

Soroka University Medical Center

Locations

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Soroka University Medical Center

Beersheba, , Israel

Site Status

Countries

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Israel

Central Contacts

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Hadar Shalev, M.D

Role: CONTACT

972506996696

Facility Contacts

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Hadar Shalev, M.D

Role: primary

Other Identifiers

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SOR495710ctil

Identifier Type: -

Identifier Source: org_study_id

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