Type 2 Diabetes MellitusNCT01107132
Blood-retinal Barrier Imaging and Neuropsychiatric Sequela in Type 2 Diabetes Mellitus
An observational study of Type 2 Diabetes Mellitus and Non-Proliferative Diabetic Retinopathy, run by Soroka University Medical Center at 1 site in Israel.
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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus, Non-Proliferative Diabetic Retinopathy, Diabetic Macular Edema
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- May 2010to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Type 2 Diabetes Mellitus Patient suffering from Non-Proliferative Diabetic Retinopathy (NPDR), Proliferative Diabetic Retinopathy (PDR) and Diabetic Macular Edema
Who may be able to join
- 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
- Patients which their medical records are available via a computerized data base
- Control group:
- T2DM patients who are in the clinical database of the ophthalmologic department
- Above 18 years old at the time of diagnosis
- Underwent FA examination in the past three years and their examination was interpreted as "normal", i.e. without suspected diabetic retinopathy
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Soroka University Medical Center
Beersheba
Hadar Shalev, M.D, shalev@bgu.ac.il
Hadar Shalev, M.D
About this study
Official title: Blood-retinal Barrier Imaging in Type 2 Diabetes Mellitus: a Window for Blood-brain Barrier Breakdown and Neuropsychiatric Sequela
In Type 2 Diabetes mellitus patients we will:
- quantify vasculopathy and blood-retinal barrier (BRB) leakage
- measure blood-brain barrier (BBB) permeability and neuroanatomical changes
- correlate BRB pathology with BBB breakdown, inflammatory markers and neuropsychiatric sequela
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Diabetic Retinopathy | T2DM Patient suffering from Non-Proliferative Diabetic Retinopathy (NPDR), Proliferative Diabetic Retinopathy (PDR) and Diabetic Macular Edema (DME) |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2010 (estimated)
- Study startMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Soroka University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Hadar Shalev, M.D, Principal investigator, Soroka University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01107132
- Sponsor's protocol ID
- SOR495710ctil
- Status last verified
- Apr 2010
- First submitted
- 18 Apr 2010
- Last updated
- 20 Apr 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood-retinal Barrier Imaging in Type 2 Diabetes Mellitus: a Window for Blood-brain Barrier Breakdown and Neuropsychiatric Sequela
- ClinicalTrials.gov ID
- NCT01107132
- Acronym / sponsor ID
- SOR495710ctil
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Soroka University Medical CenterUniversity, hospital or other
- Study start
- May 2010
- First posted
- 20 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In Type 2 Diabetes mellitus patients we will:
- quantify vasculopathy and blood-retinal barrier (BRB) leakage
- measure blood-brain barrier (BBB) permeability and neuroanatomical changes
- correlate BRB pathology with BBB breakdown, inflammatory markers and neuropsychiatric sequela
Study design
- Observational model
- Cohort
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diabetic Retinopathy | – | –T2DM Patient suffering from Non-Proliferative Diabetic Retinopathy (NPDR), Proliferative Diabetic Retinopathy (PDR) and Diabetic Macular Edema (DME) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Type 2 Diabetes Mellitus Patient suffering from Non-Proliferative Diabetic Retinopathy (NPDR), Proliferative Diabetic Retinopathy (PDR) and Diabetic Macular Edema
Key inclusion criteria (6 listed)
- 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
- Patients which their medical records are available via a computerized data base
- T2DM patients who are in the clinical database of the ophthalmologic department
- Above 18 years old at the time of diagnosis
- Underwent FA examination in the past three years and their examination was interpreted as "normal", i.e. without suspected diabetic retinopathy
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hadar Shalev, M.D principal investigator
Soroka University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes Mellitus and Non-Proliferative Diabetic Retinopathy, run by Soroka University Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hadar Shalev, M.D (972506996696, shalev@bgu.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2010.