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

Diabetes Clinical Trial

— REVADIAB  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03821753
• Other study ID #: K170406J
• Status: Recruiting
• Start date: January 7, 2019
• Est. completion date: June 1, 2020

Study information

• Verified date: November 2018
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Jean Pierre RIVELINE, Professor
• Phone: +33(0) 1 49 95 83 79
• Email: jeanpierre.riveline[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 1, 2020
• Est. primary completion date: May 1, 2020
• 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 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

Related Conditions & MeSH terms

• Angiography
• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetic Retinopathy
• Microangiopathy
• Microvascular Complications
• Retinal Diseases

Intervention

Other:
• Case
OCT OCT-Angiography, Retinophotography Neuropsychological tests
• Control
OCT OCT-Angiography, Retinophotography Neuropsychological tests

Locations

Country	Name	City	State
France	Hôpital Lariboisière	Paris	Ile-de-France

Sponsors (4)

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)

Country where clinical trial is conducted

France, 

Outcome

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