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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03821753
Other study ID # K170406J
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 7, 2019
Est. completion date July 8, 2021

Study information

Verified date November 2018
Source Assistance Publique - Hôpitaux de Paris
Contact n/a
Is FDA regulated No
Health authority
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 Completed
Enrollment 90
Est. completion date July 8, 2021
Est. primary completion date July 8, 2021
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 LibreĀ® (Abbott) - Controls: Patients without glycemic variability, defined by a coefficient of variation (CV) = 36%, calculated from Free Style LibreĀ® 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

Study Design


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
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