NCT03403686

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for all trials

Timeline
7mo left

Started Jan 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress93%
Jan 2018Dec 2026

First Submitted

Initial submission to the registry

January 11, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

January 11, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 19, 2018

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

September 17, 2025

Status Verified

September 1, 2025

Enrollment Period

9 years

First QC Date

January 11, 2018

Last Update Submit

September 10, 2025

Conditions

Diabetic Retinopathy

Keywords

Liver X receptorCirculating angiogenic cells

Outcome Measures

Primary Outcomes (1)

  • Assessing CD34+ cells function

    We are isolating CD34+ cells from peripheral blood and then examining the cell membrane characteristics of CD34+ cells and their in vitro function.

    from blood draw to 48 hours

Study Arms (6)

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.

Biological: blood draw

Diabetic no retinopathy

Patients with diabetes but with no evidence of diabetic retinopathy

Biological: blood draw

Diabetic with mild retinopathy

Diabetics with mild non proliferative diabetic retinopathy (NPDR).

Biological: blood draw

Diabetic with moderate retinopathy

Diabetics with moderate NPDR

Biological: blood draw

Diabetics with severe retinopathy

Diabetic with severe NPDR.

Biological: blood draw

Diabetics with proliferative diabetic retinopathy (PDR)

Diabetics with proliferative diabetic retinopathy (PDR)

Biological: blood draw

Interventions

blood drawBIOLOGICAL

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

ControlsDiabetic no retinopathyDiabetic with mild retinopathyDiabetic with moderate retinopathyDiabetics with proliferative diabetic retinopathy (PDR)Diabetics with severe retinopathy

Eligibility Criteria

Age21 Years - 98 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who have retinal abnormalities other than diabetic retinopathy will be excluded. Patients who have systemic conditions that influence hematopoietic stem cell function such as cardiovascular disease, malignant disease, diabetes, hematologic disorder, or estimated glomerular filtration rate less than 60 mL/min or who have undergone treatment with erythropoietin will be excluded. We will record all medications including antihypertensive drug treatment, treatment with statins, Angiotensin-Converting Enzyme (ACE) Inhibitors, Angiotensin Receptor Blockers (ARB) or other pharmacological agents that may influence CD34+ cell function. Baseline characteristics will be recorded, including age, lipid parameters, body mass index (BMI), blood pressure, smoking history, antioxidant intake and use of nutritional supplements.

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

RECRUITING

MeSH Terms

Conditions

Diabetic Retinopathy

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Maria B Grant, MD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Moorer

CONTACT

205 325 8674jmoorer@uabmc.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 11, 2018

First Posted

January 19, 2018

Study Start

January 11, 2018

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

September 17, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)