Clinical trial

LXR as a Novel Therapeutic Target in DR

Name
300000068
Description
Results from large clinical trials demonstrate a strong association between lipid abnormalities and progression of the most common microvascular complication, diabetic retinopathy (DR). We found that activation of a master regulator of cholesterol metabolism, the nuclear hormone receptors liver X receptors (LXRα/LXRβ), prevents DR in rodent models. In this application, we seek to understand the mechanisms responsible for the beneficial effects of LXR agonists on retina and on bone marrow (BM) to preserve the function of reparative cells while reducing inflammatory cell.
Trial arms
Trial start
2018-01-11
Estimated PCD
2024-12-31
Trial end
2024-12-31
Status
Recruiting
Treatment
blood draw
Blood sample will be obtained and CD34+ cells will be isolated for functional testing.
Arms:
Controls, Diabetic no retinopathy, Diabetic with mild retinopathy, Diabetic with moderate retinopathy, Diabetics with proliferative diabetic retinopathy (PDR), Diabetics with severe retinopathy
Size
104
Primary endpoint
Assessing CD34+ cells function
from blood draw to 48 hours
Eligibility criteria
Inclusion Criteria: * Any man or woman between the ages of 21- 98 years of age will be eligible to participate. To participate in the study as a study subject we will require: a) the subject must either carry the diagnosis of diabetes or be a healthy aged control and b) the patient be willing and have the ability to cooperate with the protocol. Exclusion Criteria: * Exclusion criteria: We will apply the following exclusion criteria: a) evidence of ongoing acute or chronic infection (HIV, Hepatitis B or C, tuberculosis); b) ongoing malignancy; c) cerebral vascular accident or cerebral vascular procedure; d) current pregnancy; e) history of organ transplantation; f) presence of a graft (to avoid any effect of the graft on inflammatory parameters; g) uremic symptoms, an estimated glomerular filtration rate of less than 20 cc/min (by Modification of Diet in Renal Disease equation), or an albumin of less than 3.6 (to avoid malnutrition as a confounding variable); h) be unwilling to abstain from drinking alcohol and i) patients with anemia. Subjects with AMD, glaucoma, uveitis, known hereditary degenerations or other significant ocular complications other than diabetic retinopathy will be excluded.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'OTHER'}, 'enrollmentInfo': {'count': 104, 'type': 'ESTIMATED'}}
Updated at
2023-08-08

1 organization

1 product

1 indication

Product
Blood Draw