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RecruitingNCT07556497Updated Apr 29, 2026

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

An observational study in Diabete Type 2 and Cardio Vascular Disease, sponsored by Weill Cornell Medical College in Qatar. Recruiting at 1 site in Qatar. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-29.

Sponsored by Weill Cornell Medical College in Qatar · Observational

From the registry’s dates

  • Started Nov 2020; still recruiting 5 years 11 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
90
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

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.

02

Conditions studied

  • Diabete Type 2
  • Cardio Vascular Disease
03

In context

Diabetes Mellitus, Type 2

10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.

This study's planned enrollment of 90 is below the median of 300 across 1,741 observational studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Weill Cornell Medical College in Qatar is the lead sponsor of 13 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Participants will be recruited from Hamad Medical Corporation.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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. , chronic hepatitis).
  • Evidence of within the past 5 years
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
90 participants (estimated)
Target follow-up
6 Months
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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)

06

What researchers measure

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).

  5. Angiogenic Transcription Factor Expression in EPCs

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

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

  6. Proportion of EPCs differentiating into endothelial cells in vitro

    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.

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

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

    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.

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

  8. Functional Outcomes of Genetically Enhanced Endothelial Progenitor Cells

    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.

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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided — ongoing discussion with the sponsor.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07556497
Lead sponsor
Weill Cornell Medical College in Qatar
Responsible party
Sponsor
First posted
Apr 29, 2026
Start date
Nov 17, 2020
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Apr 29, 2026

Study contacts

Charbel Abi Khalil, MD,PhD
principal investigator · Weill Cornell Medicine-Qatar

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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