Role of Endothelial Progenitor Cells Dysregulation and Inflammation in the Pathophysiology of Cardiovascular Complications of Type 2 Diabetes

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorWeill Cornell Medical College in Qatar

About this trial

This study aims to isolate endothelial progenitor cells (EPCs) from participants with type 2 diabetes (T2D) and cardiovascular complications and to comprehensively characterize EPC dysfunction. Specifically, the study will evaluate maladaptive angiocrine signaling, calcium signaling pathways, and the role of inflammation in EPC function and the progression of atherosclerosis during T2D development. A sub-study will assess EPC functionality by examining endothelial nitric oxide synthase (eNOS) expression and activity, as well as the effectiveness of in vitro eNOS gene enhancement.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

T2D

Males and females

Older than 18 years of age

Willingness to participate in the study and provide written consent form

Disqualifiers

Unable to meet the inclusion criteria

Type I diabetes, MODY diabetes or other form of diabetes

Active infection, inflammation, cancer or acute illness of any kind (other than a cardiovascular complication of diabetes if applicable in the group they are assigned to).

Chronic inflammation (eg. auto-immune diseases) or infections (eg. HIV, chronic hepatitis).

Trial population

Participants will be recruited from Hamad Medical Corporation.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

90 Participants
are grouped into 3 trial groups
Group A: Groupe 1: T2D and no established cardiovascular complications
Group B: Groupe 2: T2D and established coronary artery disease
Group C: Groupe 3: Control, no T2D

Trial outcomes

Primary outcomes

1

Characterization of EPCs dysregulation in Type 2 diabetes

Functional characterization of endothelial progenitor cells (EPCs) isolated from participants will be performed by assessing cellular signaling and functional pathways. Measurements will be compared among EPCs isolated from participants with type 2 diabetes and cardiovascular diseases, participants with type 2 diabetes without cardiovascular diseases, and healthy volunteers without diabetes or cardiovascular diseases.

Time frame
Following the EPC isolation (15 - 20 days).
2

Functional Analysis of inflammatory responses in Endothelial Progenitor Cells in type 2 Diabetes with cardiovascular complications

Functional characterization of endothelial progenitor cells (EPCs) isolated from participants will be performed by assessing cellular signaling and functional pathways. Measurements will be compared among EPCs isolated from participants with type 2 diabetes and cardiovascular diseases, participants with type 2 diabetes without cardiovascular diseases, and healthy volunteers without diabetes or cardiovascular diseases.

Time frame
Following the EPC isolation (15 - 20 days)

Secondary outcomes

1

Expression levels of angiocrine factor genes in EPCs

Expression levels of angiocrine related genes in EPCs measured by RNA sequencing and reported as normalized transcript counts.

Time frame
Following the EPC isolation (15-20 days)
2

Cytosolic calcium concetration in EPCs

Cytosolic calcium concentration and expression of calcium signaling transcripts and proteins in EPCs assessed using functional calcium assays and molecular analyses.

Time frame
Following the EPC isolation (15-20 days)
3

Quantification of Mitochondrial reactive oxygen species (ROS) levels in EPCs

Mitochondrial ROS production in EPCs measured using pre-designed fluorescence-based assay kits and reported as relative fluorescence units. Comparisons will be made among the three study groups.

Time frame
Following the EPC isolation (15-20 days).
4

Protein Expression of Inflammatory Transcription Factors in Endothelial Progenitor Cells

Protein expression levels in lysates are quantified using western blot analysis and normalized to housekeeping proteins.

Time frame
Following the EPC isolation (15 - 20 days).

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Weill Cornell Medical College in Qatar

Lead sponsor

Hamad Medical Corporation

Collaborator