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

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ClinicalTrials.gov Identifier: NCT03821753
Recruitment Status : Recruiting
First Posted : January 30, 2019
Last Update Posted : January 30, 2019
Sponsor:
Collaborators:
Délégation de la Recherche Clinique et de l'innovation (DRCI)
CRC (Centre de Recherche Clinique)
SFD (Société Francophone du Diabète)
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.


Condition or disease Intervention/treatment
Microvascular Complications Diabetic Retinopathy Diabetes Microangiopathy Angiography Other: Case Other: Control

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.

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: The Effect of the Glycemic Variability on Macular Retinal Microcirculation and Cognitive Functions in Patient With Type 1 Diabetes
Actual Study Start Date : January 7, 2019
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Group/Cohort Intervention/treatment
Case
Patients with glycemic variability, defined by a coefficient of variation (CV)> 36%, calculated from continuous glucose measurements data by Free Style Libre® (Abbott)
Other: Case
  • OCT
  • OCT-Angiography,
  • Retinophotography
  • Neuropsychological tests

Control
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%)
Other: Control
  • OCT
  • OCT-Angiography,
  • Retinophotography
  • Neuropsychological tests




Primary Outcome Measures :
  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 Outcome Measures :
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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%).

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03821753


Contacts
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Contact: Jean Pierre RIVELINE, Professor +33(0) 1 49 95 83 79 jeanpierre.riveline@aphp.fr

Locations
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France
Hôpital Lariboisière Recruiting
Paris, Ile-de-France, France, 75475
Contact: Jean-Pierre RIVELINE, Professor    +33(0) 1 49 95 83 79    jeanpierre.riveline@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Délégation de la Recherche Clinique et de l'innovation (DRCI)
CRC (Centre de Recherche Clinique)
SFD (Société Francophone du Diabète)

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03821753     History of Changes
Other Study ID Numbers: K170406J
First Posted: January 30, 2019    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Diabetic retinopathy
Glycemic variability
Diabetes
Macular retinal microcirculation
Microangiopathy
Cognitive dysfunction

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Retinal Diseases
Diabetic Retinopathy
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications