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

NCT07556497 | Recruiting

• 1 other identifier: 18-00008
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabete Type 2; Cardio Vascular Disease

Outcome Measures

Primary Outcomes (2)

• 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.

  Following the EPC isolation (15 - 20 days).

• 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.

  Following the EPC isolation (15 - 20 days)

Secondary Outcomes (8)

• Expression levels of angiocrine factor genes in EPCs

  Following the EPC isolation (15-20 days)

• Cytosolic calcium concetration in EPCs

  Following the EPC isolation (15-20 days)

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

  Following the EPC isolation (15-20 days).

• Protein Expression of Inflammatory Transcription Factors in Endothelial Progenitor Cells

  Following the EPC isolation (15 - 20 days).

• Angiogenic Transcription Factor Expression in EPCs

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

Study Arms (3)

Groupe 1: T2D and no established cardiovascular complications

* HbA1C level ≥ 6.5% and a fasting glucose level ≥126 mg/dl (7.0 mmol/l) * No concomitant cardiovascular complications (coronary artery disease, stroke, nephropathy, retinopathy, peripheral arterial disease) per the history, medical records and biochemistry.

Groupe 2: T2D and established coronary artery disease

* The presence of coronary artery disease (CAD) confirmed by coronary angiogram prior to the inclusion. * Patients with concomitant microvascular complications of diabetes will be excluded (nephropathy, retinopathy).

Groupe 3: Control, no T2D

* Fasting glycemia \<100 mg/dl and HbA1C \<5.7% * Absence of a concomitant cardiovascular disease (CAD, stroke, PAD, neuropathy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited from Hamad Medical Corporation.

You may qualify if:

• T2D
• Males and females
• Older than 18 years of age
• Willingness to participate in the study and provide written consent form
• Consent to having peripheral blood withdrawals and urine collection for the study requirement.

You may not qualify if:

• 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).
• Evidence of malignancy within the past 5 years

Sponsors & Collaborators

• Weill Cornell Medical College in Qatar: lead
• Hamad Medical Corporation: collaborator

Study Sites (1)

Hamad Medical Corporation

Doha, Qatar

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood/Urine

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Charbel Abi Khalil, MD,PhD

  Weill Cornell Medicine-Qatar

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2026
• First Posted: April 29, 2026
• Study Start: November 17, 2020
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-02

Locations

QA (1)