NCT00839150

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

February 6, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 9, 2009

Completed
Last Updated

September 19, 2011

Status Verified

June 1, 2009

Enrollment Period

1.7 years

First QC Date

February 6, 2009

Last Update Submit

September 16, 2011

Conditions

Diabetes Mellitus, Type 1Diabetes Mellitus, Type 2

Keywords

Diabetic retinopathyColor visionContrast sensitivityElectroretinogramFlicker-induced vasodilatationDynamic Vessel Analyzer

Study Arms (2)

1

Diabetic patients without diabetic retinopathy : No intervention

2

Sex and age-matched control subjects : No intervention

Eligibility Criteria

Age20 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • 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

You may not qualify if:

  • \*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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Lariboisiere

Paris, 75010, France

Location

Related Publications (1)

  • 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.

    PMID: 21282578DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetes Mellitus, Type 2Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesRetinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes Complications

Study Officials

  • Pascale Massin, MD,Pr;PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2009

First Posted

February 9, 2009

Study Start

May 1, 2005

Primary Completion

January 1, 2007

Study Completion

May 1, 2007

Last Updated

September 19, 2011

Record last verified: 2009-06

Locations

FR(1)