Diabetes Mellitus, Type 1NEURODIABNCT00839150
Retinal Function in Diabetic Patients Without Retinopathy
An observational study of Diabetes Mellitus, Type 1 and Diabetes Mellitus, Type 2, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The primary purpose was to assess, in diabetic patients without diabetic retinopathy and control subjects, color vision, contrast sensitivity, electroretinography, and flicker-induced vasodilatation using the Dynamic Vessel Analyzer, in order to specify the earliest impaired retinal cells in diabetes, and gain more… Read more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
- How many people
- 56 participants
- Where
- 1 siteFrance
- Study dates
- May 2005to May 2007
- 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 20 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: For diabetic patients : age between 20 and 55 type 1 or type 2 diabetes mellitus diabetes duration of more than 5 years no diabetic retinopathy on fundus examination or fundus photographs For control subjects : sex and age matching with the diabetic patients no diabetes, no familial or personal history of elevated blood sugar
Who may be able to join
- For diabetic patients :
- age between 20 and 55
- type 1 or type 2 diabetes mellitus
- diabetes duration of more than 5 years
- no diabetic retinopathy on fundus examination or fundus photographs
- For control subjects :
- sex and age matching with the diabetic patients
- no diabetes, no familial or personal history of elevated blood sugar
Who cannot join
- For both diabetic patients and control subjects :
- presence of cataract or history of cataract surgery
- intraocular pressure of more than 21 mmHg
- abnormal score on the Ishihara test
- other ocular disease
- ametropia more than 3 diopters, anisometropia more than 1 diopter, astigmatism more than 1 diopter
Show all 9Show fewer
- systemic hypertension (defined as systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg)
- treatment with vasoactive drugs
- tobacco consumption of more than 20 cigarettes a day
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Retinal Functional Abnormalities in Diabetic Patients Without Retinopathy
The primary purpose was to assess, in diabetic patients without diabetic retinopathy and control subjects, color vision, contrast sensitivity, electroretinography, and flicker-induced vasodilatation using the Dynamic Vessel Analyzer, in order to specify the earliest impaired retinal cells in diabetes, and gain more insight into diabetic retinopathy pathogenesis.
Read the detailed description
Type 1 and type 2 diabetic patients with no diabetic retinopathy and no hypertension were compared with sex and age-matched control subjects. Color vision was tested with the desaturated LANTHONY 15-Hue test. Contrast sensitivity was assessed with the Pelli-Robson contrast sensitivity test. Pattern-electroretinogram, Ganzfeld full-field electroretinogram and multifocal electroretinogram were recorded according to the International Society for Clinical Electrophysiology of Vision (ISCEV). Flicker-induced vasodilatation in retinal arteries and veins was assessed using the Dynamic Vessel Analyzer.
- Keywords
- Diabetic retinopathy, Color vision, Contrast sensitivity, Electroretinogram, Flicker-induced vasodilatation, Dynamic Vessel Analyzer
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Diabetic Retinopathy
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 |
|---|---|---|
| 1 | Diabetic patients without diabetic retinopathy : No intervention | |
| 2 | Sex and age-matched control subjects : No intervention |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2009 (estimated)
- Study startMay 2005
- Primary completionJan 2007
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pascale Massin, MD,Pr;PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00839150
- Sponsor's protocol ID
- P041009
- Acronym
- NEURODIAB
- Status last verified
- Jun 2009
- First submitted
- 6 Feb 2009
- Last updated
- 19 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lecleire-Collet A, Audo I, Aout M, Girmens JF, Sofroni R, Erginay A, Le Gargasson JF, Mohand-Said S, Meas T, Guillausseau PJ, Vicaut E, Paques M, Massin P. Evaluation of retinal function and flicker light-induced retinal vascular response in normotensive patients with diabetes without retinopathy. Invest Ophthalmol Vis Sci. 2011 May 2;52(6):2861-7. doi: 10.1167/iovs.10-5960.
PubMed 21282578
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Retinal Functional Abnormalities in Diabetic Patients Without Retinopathy
- ClinicalTrials.gov ID
- NCT00839150
- Acronym / sponsor ID
- NEURODIAB / P041009
- Keywords
- Diabetic retinopathy, Color vision, Contrast sensitivity, Electroretinogram, Flicker-induced vasodilatation, Dynamic Vessel Analyzer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- May 2005
- Primary completion
- Jan 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 9 Feb 2009 (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.
The primary purpose was to assess, in diabetic patients without diabetic retinopathy and control subjects, color vision, contrast sensitivity, electroretinography, and flicker-induced vasodilatation using the Dynamic Vessel Analyzer, in order to specify the earliest impaired retinal cells in diabetes, and gain more insight into diabetic retinopathy pathogenesis.
Detailed description
Type 1 and type 2 diabetic patients with no diabetic retinopathy and no hypertension were compared with sex and age-matched control subjects. Color vision was tested with the desaturated LANTHONY 15-Hue test. Contrast sensitivity was assessed with the Pelli-Robson contrast sensitivity test. Pattern-electroretinogram, Ganzfeld full-field electroretinogram and multifocal electroretinogram were recorded according to the International Society for Clinical Electrophysiology of Vision (ISCEV). Flicker-induced vasodilatation in retinal arteries and veins was assessed using the Dynamic Vessel Analyzer.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Diabetic patients without diabetic retinopathy : No intervention |
| 2 | – | –Sex and age-matched control subjects : No intervention |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- For diabetic patients : age between 20 and 55 type 1 or type 2 diabetes mellitus diabetes duration of more than 5 years no diabetic retinopathy on fundus examination or fundus photographs For control subjects : sex and age matching with the diabetic patients no diabetes, no familial or personal history of elevated blood sugar
Key inclusion criteria (8 listed)
- For diabetic patients :
- For control subjects :
Key exclusion criteria (9 listed)
- presence of cataract or history of cataract surgery
- intraocular pressure of more than 21 mmHg
- abnormal score on the Ishihara test
- other ocular disease
- ametropia more than 3 diopters, anisometropia more than 1 diopter, astigmatism more than 1 diopter
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
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2011.
- Derived from this study: PubMed 21282578Lecleire-Collet A, Audo I, Aout M, Girmens JF, Sofroni R, Erginay A, Le Gargasson JF, Mohand-Said S, Meas T, Guillausseau PJ, Vicaut E, Paques M, Massin P. Evaluation of retinal function and flicker light-induced retinal vascular response in normotensive patients with diabetes without retinopathy. Invest Ophthalmol Vis Sci. 2011 May 2;52(6):2861-7. doi: 10.1167/iovs.10-5960.
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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.
Pascale Massin, MD,Pr;PhD principal investigator
Assistance Publique - Hôpitaux de Paris
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 Diabetes Mellitus, Type 1 and Diabetes Mellitus, Type 2, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 8 inclusion and 9 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: finished, as of the sponsor's last update on 19 Sep 2011. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00839150, which also lists 1 linked publication.
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 19 Sep 2011.