Diabetes Clinical Trial
— REVADIABOfficial title:
The Effect of the Glycemic Variability on Macular Retinal Microcirculation and Cognitive Functions in Patient With Type 1 Diabetes
NCT number | NCT03821753 |
Other study ID # | K170406J |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 7, 2019 |
Est. completion date | July 8, 2021 |
Verified date | November 2018 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Revadiab is case-control study aimed to demonstrate that retinal capillary density is altered in patients with type 1 diabetes with glycemic variability compared to those with comparable glycemic control without glycemic variability. An OCT angiography will be used to precisely evaluate retinal capillary density. A secondary objective will be to evaluate if glycemic variability is associated with cognitive dysfunction, using a neuro psychologic evaluation.
Status | Completed |
Enrollment | 90 |
Est. completion date | July 8, 2021 |
Est. primary completion date | July 8, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients = 18 years - Type 1 diabetes (T1D) - Using Free FreeStyle - Diabete evolving for 10 years or more - Case: Patients with glycemic variability, defined by a coefficient of variation (CV) > 36%, calculated from continuous glucose measurements data by Free Style LibreĀ® (Abbott) - Controls: Patients without glycemic variability, defined by a coefficient of variation (CV) = 36%, calculated from Free Style LibreĀ® data and matched to patients in the Case group for HbA1c (+/- 0.5%) Exclusion Criteria: - Type 2 diabetic patient - Corticotherapy - Comorbidity like cancer - Antecedent of vitreoretinal pathology - Antecedent of vitreoretinal surgery - Important cataract, with an important opacity that prevents a reliable evaluation of capillary density in OCT angio - Pregnant or lactating woman |
Country | Name | City | State |
---|---|---|---|
France | Hôpital Lariboisière | Paris | Ile-de-France |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris | CRC (Centre de Recherche Clinique), Délégation de la Recherche Clinique et de l'innovation (DRCI), SFD (Société Francophone du Diabète) |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Macular capillary density in the external deep capillary network | Macular capillary density in the external deep capillary network measured by OCT-Angiography (no later than 3 months after inclusion) | 3 months | |
Secondary | Macular capillary density in the deep capillary and deep capillary network | Macular capillary density in the deep capillary and deep capillary network measured by OCT-angiography (no later than 3 months after inclusion) | 3 months | |
Secondary | Area of the central avascular zone | Area of the central avascular zone by OCT-Angiography (no later than 3 months after inclusion) | 3 months | |
Secondary | Macular edema presence | Macular edema presence by OCT (no later than 3 months after inclusion) | 3 months | |
Secondary | Layer thickness reduction of the ganglion cells | Layer thickness reduction of the ganglion cells measured by OCT (no later than 3 months after inclusion) | 3 months | |
Secondary | Diabetic retinopathy stage | Diabetic retinopathy stage evaluated with retinographies (no later than 3 months after inclusion) | 3 months | |
Secondary | Development of pre-retinal neovascular vessels and/or pre-papillary | Development of pre-retinal neovascular vessels and/or pre-papillary (no later than 3 months after inclusion) | 3 months | |
Secondary | Occurrence of neovascular complications | Occurrence of neovascular complications: vitreous | 3 months | |
Secondary | Haemorrhage, retina tractional detachment, neovascular glaucoma | Haemorrhage, retina tractional detachment, neovascular glaucoma (no later than 3 months after inclusion) | 3 months | |
Secondary | Renal function evaluation | Renal function evaluation: microalbuminuria and creatinine determination (no later than 3 months after inclusion) | 3 months | |
Secondary | Evaluation of peripheral neuropathy | Evaluation of peripheral neuropathy : monofilament test (no later than 3 months after inclusion) | 3 months | |
Secondary | Ischemic cardiopathy | Measurement method: treatment with angioplasty or coronary artery bypass graft, Assessment of vascular risk by measuring the coronal calcium score, and determination of BNP and troponin. (no later than 3 months after inclusion) | 3 months | |
Secondary | Number of severe hypoglycemia | Number of severe hypoglycemia since 1 year, threshold for hypoglycemia no later than 3 months after inclusion) | 3 months | |
Secondary | Markers of inflammation | characterization of circulating inflammatory and endothelial cells and CRP-US assay | 3 months | |
Secondary | Oxidative stress markers | Oxidative stress markers: Measurements of 8-iso-prostaglandin F2 alpha urinary and 1,5-anhydroglucitol sanguine. (no later than 3 months after inclusion) | 3 months |
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