Clinical trial NCT03821753: The Effect of the Glycemic Variability on Macular Retinal Microcirculation and Cognitive Functions in Patient With Type 1 Diabetes
Official title: The Effect of the Glycemic Variability on Macular Retinal Microcirculation and Cognitive Functions in Patient With Type 1 Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Microvascular Complications
Diabetic Retinopathy
Diabetes
Microangiopathy
Angiography
Keywords: Diabetic retinopathy
Glycemic variability
Diabetes
Macular retinal microcirculation
Microangiopathy
Cognitive dysfunction
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Délégation de la Recherche Clinique et de l'innovation (DRCI)
name: CRC (Centre de Recherche Clinique)
name: SFD (Société Francophone du Diabète)
First posted: 2019-01-30
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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%).

Brief summary: 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.

Detailed description: 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 :

* 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.

Eligibility criteria: 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 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:

* 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

Primary outcomes:
measure: Macular capillary density in the external deep capillary network
timeFrame: 3 months
Secondary outcomes:
measure: Macular capillary density in the deep capillary and deep capillary network
timeFrame: 3 months
measure: Area of the central avascular zone
timeFrame: 3 months
measure: Macular edema presence
timeFrame: 3 months
measure: Layer thickness reduction of the ganglion cells
timeFrame: 3 months
measure: Diabetic retinopathy stage
timeFrame: 3 months
measure: Development of pre-retinal neovascular vessels and/or pre-papillary
timeFrame: 3 months
measure: Occurrence of neovascular complications
timeFrame: 3 months
measure: Haemorrhage, retina tractional detachment, neovascular glaucoma
timeFrame: 3 months
measure: Renal function evaluation
timeFrame: 3 months
measure: Evaluation of peripheral neuropathy
timeFrame: 3 months
measure: Ischemic cardiopathy
timeFrame: 3 months
measure: Number of severe hypoglycemia
timeFrame: 3 months
measure: Markers of inflammation
timeFrame: 3 months
measure: Oxidative stress markers
timeFrame: 3 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Lariboisière
state: Ile-de-France
Study officials:
References: