Non Proliferative Diabetic Retinopathy, Proliferative Diabetic Retinopathy
Conditions
Brief summary
Homocysteine, a well-known inducer of vascular endothelial cell damage has been associated with extracellular matrix changes. Many studies demonstrated that high levels of this aminoacid in diabetic patients increases significantly the risk of the development of this pathology. This study has been undertaken to investigate the role of homocysteine and its cofactors (folic acid, vitamin B6 and B12) during the progression of the diabetic retinopathy.
Interventions
DRUGFolic Acid, vit B6 and B12
DRUGPlacebo
Sponsors
University of Catania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* diabetic patients with proliferative and non proliferative retinopathy
Exclusion criteria
* Patients with chronic liver disease Patients with kidney disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| homocysteine | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| folic acid | 12 months |
Other
| Measure | Time frame |
|---|---|
| vitamin B6 | 12 months |
| vitamin B12 | 12 months |
Countries
Italy
Contacts
Primary ContactMariano Malaguarnera, A.P.
Outcome results
None listed