Type 1 Diabetes Patients Clinical Trial
— AwARDOfficial title:
Early Stage Retinal Abnormalities in Type 1 Diabetes, Screened With OCT Angiography.
NCT number | NCT03496597 |
Other study ID # | VERGES 2017 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | February 23, 2018 |
Est. completion date | August 2023 |
Verified date | March 2022 |
Source | Centre Hospitalier Universitaire Dijon |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The improvement of imaging techniques in ophthalmology has made it possible to carry out a precise non-invasive study of the retinal microvascular network and to detect early abnormalities in retinal disorders. The presence of such early retinal abnormalities remains poorly known during type 1 diabetes and may be detected with OCT-angiography. Furthermore, the association with glycemic variability, likely to have deleterious effects on microvessels, has never been studied.
Status | Recruiting |
Enrollment | 520 |
Est. completion date | August 2023 |
Est. primary completion date | August 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: For the patient group - Patient who has given consent - Type 1 diabetic patient, no retinopathy For the healthy control group - Patient who has given consent - Non-diabetic patient For dyslipidemic control group: - Person who has given consent - Person with familial dyslipidemia Exclusion Criteria: For the patient group - Presence of diabetic retinopathy - Protected patient: - Minor patient - Pregnant, parturient or breastfeeding woman - Patient under legal protection (guardianship, curatorship, court decision) - Patient unable to express consent Person not affiliated to a health insurance scheme For the healthy control group - Ophthalmological history (vascular and degenerative macular conditions) - Protected patient: - Minor patient - Pregnant, parturient or breastfeeding woman - Patient under legal protection (guardianship, curatorship, court decision) - Patient unable to express consent Person not affiliated to a social security scheme For dyslipidemic control group: - Ophthalmological history (vascular and degenerative macular conditions) - Protected patient: - Minor patient - Pregnant, parturient or breastfeeding woman - Patient under legal protection (guardianship, curatorship, court decision) - Patient unable to express consent Person not affiliated to a social security scheme |
Country | Name | City | State |
---|---|---|---|
France | CHU Dijon Bourgogne | Dijon |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire Dijon |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | surface of the central retinal avascular zone | measurement of superficial capillary plexus | inclusion |