The Effect of the Glycemic Variability on Macular Retinal Microcirculation and Cognitive Functions in Patient With Type 1 Diabetes
NCT ID: NCT03821753
Last Updated: 2024-06-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
90 participants
OBSERVATIONAL
2019-01-07
2021-07-08
Brief Summary
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A secondary objective will be to evaluate if glycemic variability is associated with cognitive dysfunction, using a neuro psychologic evaluation.
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Detailed Description
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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 :
* Alteration of cognitive functions.
* Severity of peripheral diabetic retinopathy and retinal neuronal damage.
* Other micro and macro angiopathic complications.
* Oxidative stress and inflammation.
Two groups of type 1 diabetic patients will be compared:
* Case: Patient with significant glycemic variability.
* Control: Patients without glycemic variability.
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 :
* Non-invasive retinal imaging (OCT and OCT- Angiography, retinophotography)
* Neuropsychological tests.
* Blood test.
Conditions
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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Case
Patients with glycemic variability, defined by a coefficient of variation (CV)\> 43%, calculated from continuous glucose measurements data by Free Style Libre® (Abbott)
Case
* OCT
* OCT-Angiography,
* Retinophotography
* Neuropsychological tests
Control
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%)
Control
* OCT
* OCT-Angiography,
* Retinophotography
* Neuropsychological tests
Interventions
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Case
* OCT
* OCT-Angiography,
* Retinophotography
* Neuropsychological tests
Control
* OCT
* OCT-Angiography,
* Retinophotography
* Neuropsychological tests
Eligibility Criteria
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Inclusion Criteria
* 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 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%)
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Délégation de la Recherche Clinique et de l'innovation (DRCI)
UNKNOWN
CRC (Centre de Recherche Clinique)
UNKNOWN
SFD (Société Francophone du Diabète)
UNKNOWN
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Locations
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Hôpital Lariboisière
Paris, Île-de-France Region, France
Countries
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Other Identifiers
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K170406J
Identifier Type: -
Identifier Source: org_study_id
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