The Effect of the Glycemic Variability on Macular Retinal Microcirculation

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03821753
Study type	Observational
Source	Assistance Publique - Hôpitaux de Paris
Contact	Jean Pierre RIVELINE, Professor
Phone	+33(0) 1 49 95 83 79
Email	jeanpierre.riveline@aphp.fr
Status	Recruiting
Phase
Start date	January 7, 2019
Completion date	June 1, 2020

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

The Effect of the Glycemic Variability on Macular Retinal Microcirculation and Cognitive Functions in Patient With Type 1 Diabetes — REVADIAB

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms