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NCT Number: NCT07556497

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

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.

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Key information

Conditions

Diabete Type 2 Cardio Vascular Disease Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

Type 2 diabetes (T2D) is associated with damage to blood vessels, which can lead to serious complications such as heart disease, stroke, and other vascular problems.

Endothelial progenitor cells (EPCs) help maintain healthy blood vessels by repairing vascular injury. In people with T2D, the number and function of these cells are reduced, which may contribute to poor blood vessel repair and increased cardiovascular risk. The mechanisms responsible for this dysfunction are not fully understood. This study aims to examine how changes in cell signaling and chronic low-grade inflammation in T2D affect EPC function. EPCs will be isolated from patients with T2D, with and without cardiovascular complications, to assess their signaling properties, function, and ability to mature into vascular cells.

An in vitro sub-study will evaluate a potential therapeutic strategy to improve EPC function by increasing the activity of endothelial nitric oxide synthase (eNOS), a protein that plays a key role in maintaining healthy blood vessels. Reduced eNOS activity is an important contributor to vascular dysfunction in diabetes. Enhancing eNOS expression and function in EPCs may improve their regenerative capacity and help prevent or treat diabetic vascular complications.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Characterization of EPCs dysregulation in Type 2 diabetes

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

    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.

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

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

    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.

Secondary outcomes

  1. Expression levels of angiocrine factor genes in EPCs

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

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

  2. Cytosolic calcium concetration in EPCs

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

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

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

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

    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.

  4. Protein Expression of Inflammatory Transcription Factors in Endothelial Progenitor Cells

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

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

  5. Angiogenic Transcription Factor Expression in EPCs

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

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

  6. Proportion of EPCs differentiating into endothelial cells in vitro

    Time frame: 14 days after initiation of in vitro differentiation.

    Differentiation of EPCs into adherent endothelial cells following culture in VEGF-, FGF-2-, IGF-1-, and heparin-supplemented media, assessed by endothelial morphology and marker expression.

  7. Measurement of eNOS(endothelial nitric oxide synthase)-Dependent Nitric Oxide Production in Endothelial Progenitor Cells

    Time frame: Following EPC isolation (15-20 days) and 72 hours post-gene transfection.

    eNOS(endothelial nitric oxide synthase) mRNA expression measured by RT-PCR and eNOS protein expression measured by western blotting in EPCs isolated from participants with type 2 diabetes and healthy volunteers.

  8. Functional Outcomes of Genetically Enhanced Endothelial Progenitor Cells

    Time frame: Following EPC isolation (15-20 days) and 72 hours post-gene transfection

    eNOS mRNA expression measured by RT-PCR and eNOS protein expression measured by western blotting in EPCs isolated from participants with type 2 diabetes and healthy volunteers.

Sponsors and collaborators

Lead sponsor

Weill Cornell Medical College in Qatar

Other

Collaborators

  • Hamad Medical Corporation

Registry information

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Apr 29, 2026
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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