An observational study in Microvascular Complications, Diabetic Retinopathy and Diabetes, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-10.
Sponsored by Assistance Publique - Hôpitaux de Paris · 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.
HbA1c doesn't explain all the microvascular complications of diabetes, especially microvascular complications. Glycemic variability is associated with increased oxidative stress, free radicals and endothelial dysfunction; it contributes to the pathogenesis of diabetic complications.
The relationship between glycemic variability and microangiopathic complications especially retinal but also neurological, needs to be studied.
The principal objective of Revadiab study is to demonstrate a correlation between glycemic variability and macular retinal microcirculation in patient with type 1 diabetes.
The secondary objective is to search a correlation between glycemic variability and :
Two groups of type 1 diabetic patients will be compared:
The severity of diabetic retinopathy will be evaluated by the degree of occlusion of small vessels in the central retinal region as measured by OCT angiography.
Acts or Product necessary to research :
791 studies on the registry are indexed under Diabetic Retinopathy; 139 are open to participants now.
This study's enrollment of 90 is below the median of 150 across 268 observational studies indexed under Diabetic Retinopathy.
Browse Diabetic Retinopathy studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,576 studies on the registry; 1,028 are open to participants now.
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Inclusion of adult patients with T1D with more than 10 years of diabetes and users of the FreeStyle Free continuous measurement system.
Case: Patients with glycemic variability, defined by a coefficient of variation (CV) > 36%, calculated from continuous glucose measurements data by Free Style Libre® (Abbott).
Controls: Patients without glycemic variability, defined by a coefficient of variation (CV) ≤ 36%, calculated from Free Style Libre® data and matched to patients in the Case group for HbA1c (+/- 0.5%).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients with glycemic variability, defined by a coefficient of variation (CV)\> 43%, calculated from continuous glucose measurements data by Free Style Libre® (Abbott)
Other: Case
Patients without glycemic variability, defined by a coefficient of variation (CV) ≤ 43%, calculated from Free Style Libre® data and matched to patients in the Case group for HbA1c (+/- 0.5%)
Other: Control
* OCT * OCT-Angiography, * Retinophotography * Neuropsychological tests
* OCT * OCT-Angiography, * Retinophotography * Neuropsychological tests
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)
Time frame: 3 months
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)
Time frame: 3 months
Area of the central avascular zone
Area of the central avascular zone by OCT-Angiography (no later than 3 months after inclusion)
Time frame: 3 months
Macular edema presence
Macular edema presence by OCT (no later than 3 months after inclusion)
Time frame: 3 months
Layer thickness reduction of the ganglion cells
Layer thickness reduction of the ganglion cells measured by OCT (no later than 3 months after inclusion)
Time frame: 3 months
Diabetic retinopathy stage
Diabetic retinopathy stage evaluated with retinographies (no later than 3 months after inclusion)
Time frame: 3 months
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)
Time frame: 3 months
Occurrence of neovascular complications
Occurrence of neovascular complications: vitreous
Time frame: 3 months
Haemorrhage, retina tractional detachment, neovascular glaucoma
Haemorrhage, retina tractional detachment, neovascular glaucoma (no later than 3 months after inclusion)
Time frame: 3 months
Renal function evaluation
Renal function evaluation: microalbuminuria and creatinine determination (no later than 3 months after inclusion)
Time frame: 3 months
Evaluation of peripheral neuropathy
Evaluation of peripheral neuropathy : monofilament test (no later than 3 months after inclusion)
Time frame: 3 months
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)
Time frame: 3 months
Number of severe hypoglycemia
Number of severe hypoglycemia since 1 year, threshold for hypoglycemia no later than 3 months after inclusion)
Time frame: 3 months
Markers of inflammation
characterization of circulating inflammatory and endothelial cells and CRP-US assay
Time frame: 3 months
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)
Time frame: 3 months
Plan to share: No
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This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.
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