Retinal Function in Diabetic Patients Without Retinopathy | NCT00839150

Studies
Retinal Function in Diabetic Patients Without Retinopathy

NCT00839150

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Completed

Last Update Posted

Sep 19, 2011Estimated

Enrollment

56Actual

Phase

Not provided

Conditions

Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2005

Primary Completion Date

Jan 2007Actual

Completion Date

May 2007Actual

First Submitted Date

Feb 6, 2009

First Submission Date that Met QC Criteria

Feb 6, 2009

First Posted Date

Feb 9, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 16, 2011

Last Update Posted Date

Sep 19, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

56Actual

Label	Type	Description	Intervention Names
1		Diabetic patients without diabetic retinopathy : No intervention
2		Sex and age-matched control subjects : No intervention

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

*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
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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

55 Years

Standard Ages

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

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Pascale Massin, MD,Pr;PhD	Assistance Publique - Hôpitaux de Paris	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Hopital Lariboisiere		Paris		75010	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21282578	Derived	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.

ID	Term
D003922	Diabetes Mellitus, Type 1
D003924	Diabetes Mellitus, Type 2
D003930	Diabetic Retinopathy

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases