Microvascular ComplicationsREVADIABNCT03821753
The Effect of the Glycemic Variability on Macular Retinal Microcirculation and Cognitive Functions in Patient With Type 1 Diabetes
An observational study of Microvascular Complications and Diabetic Retinopathy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Microvascular Complications, Diabetic Retinopathy, Diabetes
- What is being tested?
- Case
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- 7 Jan 2019to 8 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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%).
Who may be able to join
- 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%)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Case, Control
- Keywords
- Diabetic retinopathy, Glycemic variability, Diabetes, Macular retinal microcirculation, Microangiopathy, Cognitive dysfunction
- Medical subject headings
- Diabetic Retinopathy, Diabetes Mellitus, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaseOther
- OCT
- OCT-Angiography,
- Retinophotography
- Neuropsychological tests
ControlOther
- OCT
- OCT-Angiography,
- Retinophotography
- Neuropsychological tests
| Study group | Role | What they receive |
|---|---|---|
| Case | Patients with glycemic variability, defined by a coefficient of variation (CV)> 43%, calculated from continuous glucose measurements data by Free Style Libre® (Abbott) Receives: Other: Case | |
| Control | Patients without glycemic variability, defined by a coefficient of variation (CV) ≤ 43%, calculated from Free Style Libre® data and matched to patients in the Case group for HbA1c (+/- 0.5%) Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 3 months
Secondary outcomes (14)
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)
Measured: 3 months
Area of the central avascular zone
Area of the central avascular zone by OCT-Angiography (no later than 3 months after inclusion)
Measured: 3 months
Macular edema presence
Macular edema presence by OCT (no later than 3 months after inclusion)
Measured: 3 months
Layer thickness reduction of the ganglion cells
Layer thickness reduction of the ganglion cells measured by OCT (no later than 3 months after inclusion)
Measured: 3 months
Diabetic retinopathy stage
Diabetic retinopathy stage evaluated with retinographies (no later than 3 months after inclusion)
Measured: 3 months
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)
Measured: 3 months
Occurrence of neovascular complications
Occurrence of neovascular complications: vitreous
Measured: 3 months
Haemorrhage, retina tractional detachment, neovascular glaucoma
Haemorrhage, retina tractional detachment, neovascular glaucoma (no later than 3 months after inclusion)
Measured: 3 months
Renal function evaluation
Renal function evaluation: microalbuminuria and creatinine determination (no later than 3 months after inclusion)
Measured: 3 months
Evaluation of peripheral neuropathy
Evaluation of peripheral neuropathy : monofilament test (no later than 3 months after inclusion)
Measured: 3 months
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)
Measured: 3 months
Number of severe hypoglycemia
Number of severe hypoglycemia since 1 year, threshold for hypoglycemia no later than 3 months after inclusion)
Measured: 3 months
Markers of inflammation
characterization of circulating inflammatory and endothelial cells and CRP-US assay
Measured: 3 months
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)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2019
- Study start7 Jan 2019
- Primary completion8 Jul 2021
- Study completion8 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microvascular ComplicationsStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Délégation de la Recherche Clinique et de l'innovation (DRCI), CRC (Centre de Recherche Clinique), Société Francophone du Diabète
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03821753
- Sponsor's protocol ID
- K170406J
- Acronym
- REVADIAB
- Status last verified
- Nov 2018
- First submitted
- 26 Nov 2018
- Last updated
- 10 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Glycemic Variability on Macular Retinal Microcirculation and Cognitive Functions in Patient With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT03821753
- Acronym / sponsor ID
- REVADIAB / K170406J
- Keywords
- Diabetic retinopathy, Glycemic variability, Diabetes, Macular retinal microcirculation, Microangiopathy, Cognitive dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Délégation de la Recherche Clinique et de l'innovation (DRCI), CRC (Centre de Recherche Clinique), Société Francophone du Diabète
- Study start
- 7 Jan 2019 (actual)
- Primary completion
- 8 Jul 2021 (actual)
- Study completion
- 8 Jul 2021 (actual)
- First posted
- 30 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | – | Other: CasePatients with glycemic variability, defined by a coefficient of variation (CV)> 43%, calculated from continuous glucose measurements data by Free Style Libre® (Abbott) |
| Control | – | Other: ControlPatients without glycemic variability, defined by a coefficient of variation (CV) ≤ 43%, calculated from Free Style Libre® data and matched to patients in the Case group for HbA1c (+/- 0.5%) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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%).
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (7 listed)
- Type 2 diabetic patient
- Corticotherapy
- Comorbidity like cancer
- Antecedent of vitreoretinal pathology
- Antecedent of vitreoretinal surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Case* OCT * OCT-Angiography, * Retinophotography * Neuropsychological tests | Other | Case |
| Control* OCT * OCT-Angiography, * Retinophotography * Neuropsychological tests | Other | Control |
Primary outcome
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)
14 secondary outcomes
Macular capillary density in the deep capillary and deep capillary network
Time frame: 3 months
Area of the central avascular zone
Time frame: 3 months
Macular edema presence
Time frame: 3 months
Layer thickness reduction of the ganglion cells
Time frame: 3 months
Diabetic retinopathy stage
Time frame: 3 months
Development of pre-retinal neovascular vessels and/or pre-papillary
Time frame: 3 months
Occurrence of neovascular complications
Time frame: 3 months
Haemorrhage, retina tractional detachment, neovascular glaucoma
Time frame: 3 months
Renal function evaluation
Time frame: 3 months
Evaluation of peripheral neuropathy
Time frame: 3 months
Ischemic cardiopathy
Time frame: 3 months
Number of severe hypoglycemia
Time frame: 3 months
Markers of inflammation
Time frame: 3 months
Oxidative stress markers
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Microvascular Complications and Diabetic Retinopathy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Macular capillary density in the external deep capillary network (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2024.