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Completed

NCT Number: NCT03821753

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

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.

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Key information

Conditions

Microvascular Complications Angiography Cardiovascular Diseases Cognition Disorders Cognitive Dysfunction Diabetes Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Retinopathy Endocrine System Diseases Eye Diseases Glucose Metabolism Disorders Mental Disorders Metabolic Diseases Microangiopathy Neurocognitive Disorders Nutritional and Metabolic Diseases Retinal Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Lariboisière

Paris, Île-de-France Region, 75475, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CASE

Other
  • OCT
  • OCT-Angiography,
  • Retinophotography
  • Neuropsychological tests

Control

Other
  • OCT
  • OCT-Angiography,
  • Retinophotography
  • Neuropsychological tests

Primary outcomes

  1. Macular capillary density in the external deep capillary network

    Time frame: 3 months

    Macular capillary density in the external deep capillary network measured by OCT-Angiography (no later than 3 months after inclusion)

Secondary outcomes

  1. Macular capillary density in the deep capillary and deep capillary network

    Time frame: 3 months

    Macular capillary density in the deep capillary and deep capillary network measured by OCT-angiography (no later than 3 months after inclusion)

  2. Area of the central avascular zone

    Time frame: 3 months

    Area of the central avascular zone by OCT-Angiography (no later than 3 months after inclusion)

  3. Macular edema presence

    Time frame: 3 months

    Macular edema presence by OCT (no later than 3 months after inclusion)

  4. Layer thickness reduction of the ganglion cells

    Time frame: 3 months

    Layer thickness reduction of the ganglion cells measured by OCT (no later than 3 months after inclusion)

  5. Diabetic retinopathy stage

    Time frame: 3 months

    Diabetic retinopathy stage evaluated with retinographies (no later than 3 months after inclusion)

  6. Development of pre-retinal neovascular vessels and/or pre-papillary

    Time frame: 3 months

    Development of pre-retinal neovascular vessels and/or pre-papillary (no later than 3 months after inclusion)

  7. Occurrence of neovascular complications

    Time frame: 3 months

    Occurrence of neovascular complications: vitreous

  8. Haemorrhage, retina tractional detachment, neovascular glaucoma

    Time frame: 3 months

    Haemorrhage, retina tractional detachment, neovascular glaucoma (no later than 3 months after inclusion)

  9. Renal function evaluation

    Time frame: 3 months

    Renal function evaluation: microalbuminuria and creatinine determination (no later than 3 months after inclusion)

  10. Evaluation of peripheral neuropathy

    Time frame: 3 months

    Evaluation of peripheral neuropathy : monofilament test (no later than 3 months after inclusion)

  11. Ischemic cardiopathy

    Time frame: 3 months

    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)

  12. Number of severe hypoglycemia

    Time frame: 3 months

    Number of severe hypoglycemia since 1 year, threshold for hypoglycemia no later than 3 months after inclusion)

  13. Markers of inflammation

    Time frame: 3 months

    characterization of circulating inflammatory and endothelial cells and CRP-US assay

  14. Oxidative stress markers

    Time frame: 3 months

    Oxidative stress markers: Measurements of 8-iso-prostaglandin F2 alpha urinary and 1,5-anhydroglucitol sanguine. (no later than 3 months after inclusion)

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • CRC (Centre de Recherche Clinique)
  • Délégation de la Recherche Clinique et de l'innovation (DRCI)
  • SFD (Société Francophone du Diabète)

Registry information

Acronym: REVADIAB

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jan 30, 2019
Registry last updated
Jun 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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