Recruiting

LXR

Sponsor:

University of Alabama at Birmingham

Code:

NCT03403686

Conditions

Diabetic Retinopathy

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Accepted

Interventions

blood draw

Study Details

Brief summary:

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.

Conditions

Diabetic Retinopathy

Study ID

NCT03403686

Start date

Jan 11, 2018

Status verified date

Sep, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

104 participants

Anticipated

Interventions and Outcome Measures

Arms

Controls

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 that the subject must carry the diagnosis of healthy control.

Diabetic no retinopathy

Patients with diabetes but with no evidence of diabetic retinopathy

Diabetic with mild retinopathy

Diabetics with mild non proliferative diabetic retinopathy (NPDR).

Diabetic with moderate retinopathy

Diabetics with moderate NPDR

Diabetics with severe retinopathy

Diabetic with severe NPDR.

Diabetics with proliferative diabetic retinopathy (PDR)

Diabetics with proliferative diabetic retinopathy (PDR)

Interventions

blood draw

Blood sample will be obtained and CD34+ cells will be isolated for functional testing.

Primary outcome measure

  • Assessing CD34+ cells function [ Time Frame: from blood draw to 48 hours ]

Central Contacts and Locations

Central contacts

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35294

Contacts

Principal Investigator:

Maria B Grant, MD

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

Sep 17, 2025

Last verified

Sep, 2025

Keywords

  • Liver X receptor
  • Circulating angiogenic cells

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2025-09-17.