Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
302 participants
INTERVENTIONAL
2013-10-16
2021-01-31
Brief Summary
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Previous studies that have examined candidate predictive factors for diabetic eye disease have mostly focused on systemic risk factors leading to PDR. Among various clinical parameters, increased HbA1c % levels, uncontrolled blood pressure, diabetes duration, neuropathy and elevated triglycerides have been associated with PDR.
Some genetic factors may also account for the development of PDR and are prospectively considered in this study .
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Detailed Description
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Secondly (2014) in a subgroup of 287 DT2 patients, investigators showed the impact of the EL rare T allele was consistent with a recessive mode of inheritance, with homozygotes for the rare allele differing from the carriers of the major allele. Importantly, the homozygotes for the rare T allele were more likely to present with advanced stages of diabetic retinopathy (severe non proliferative and proliferative disease) and particularly with proliferative diabetic retinopathy (PDR).
Based on this model investigators decided to conduct a case-control prospective study comparing 155 french patients with DT2 with PDR (cases) and 155 french patients with DT2 without PDR (controls) on the basis of two genetic parameters: EL c.584C\>T polymorphism that investigators previously studied and the C(-106)T aldose reductase polymorphism widely studied in diabetic retinopathy.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Diabetic patients with proliferative diabetic retinopathy
genetic analysis
Diabetic patients with non proliferative diabetic retinopathy
genetic analysis
Interventions
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genetic analysis
Eligibility Criteria
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Inclusion Criteria
* patient with proliferative diabetic retinopathy (for arm 1)
* patient with non proliferative diabetic retinopathy (for arm 2)
* patient older than 18 years
* patient consenting to participate to the study
* patient enrolled in the national healthcare insurance program
18 Years
ALL
No
Sponsors
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CHU de Reims
OTHER
Responsible Party
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Locations
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Chu de Reims
Reims, , France
Countries
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References
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Henry A, Boigelot T, Moura TF, Leclercq I, Barbe C, Thiery A, Djerada Z, Nazeyrollas P, Clavel C, Cornillet-Lefebvre P, Berrod JP, Creuzot-Garcher C, Meyer L, Gaucher D, Guerci B, Lenoble P, Milazzo S, Perone JM, Arndt C, Durlach V. No association of endothelial lipase and aldose reductase polymorphisms with proliferative diabetic retinopathy: Results of the French prospective multicenter REDIAGEN study. Diabetes Metab. 2024 May;50(3):101533. doi: 10.1016/j.diabet.2024.101533. Epub 2024 Apr 1. No abstract available.
Other Identifiers
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PR12040
Identifier Type: -
Identifier Source: org_study_id
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