Diabete Type 2NCT07556497
Role of Endothelial Progenitor Cells Dysregulation and Inflammation in the Pathophysiology of Cardiovascular Complications of Type 2 Diabetes
An observational study of Diabete Type 2 and Cardio Vascular Disease, run by Weill Cornell Medical College in Qatar at 1 site in Qatar.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabete Type 2, Cardio Vascular Disease
- How many people
- 90 participants
- Where
- 1 siteQatar
- Study dates
- 17 Nov 2020to 31 Dec 2026
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants will be recruited from Hamad Medical Corporation.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Qatar1 site, 1 recruiting
- Recruiting
Hamad Medical Corporation
Doha
Jassim Al Suwaidi, MD, +974 4439 5354, jalsuwaidi@hamad.qa
About this study
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.
- Conditions
- Diabete Type 2, Cardio Vascular Disease
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Following the EPC isolation (15 - 20 days)
Secondary outcomes (8)
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.
Measured: Following the EPC isolation (15-20 days)
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.
Measured: Following the EPC isolation (15-20 days)
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.
Measured: Following the EPC isolation (15-20 days).
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.
Measured: Following the EPC isolation (15 - 20 days).
Angiogenic Transcription Factor Expression in EPCs
Protein expression levels in lysates are quantified using western blot analysis and normalized to housekeeping proteins.
Measured: Time Frame: Following the EPC isolation (15 - 20 days).
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.
Measured: 14 days after initiation of in vitro differentiation.
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.
Measured: Following EPC isolation (15-20 days) and 72 hours post-gene transfection.
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.
Measured: Following EPC isolation (15-20 days) and 72 hours post-gene transfection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start17 Nov 2020
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabete Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Weill Cornell Medical College in Qatar
- Sponsor type
- University, hospital or other
- Collaborators
- Hamad Medical Corporation
- Responsible party
- Sponsor
- Investigators
- Charbel Abi Khalil, MD,PhD, Principal investigator, Weill Cornell Medicine-Qatar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07556497
- Sponsor's protocol ID
- 18-00008
- Status last verified
- Feb 2026
- First submitted
- 13 Apr 2026
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: ongoing discussion with the sponsor.
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Endothelial Progenitor Cells Dysregulation and Inflammation in the Pathophysiology of Cardiovascular Complications of Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT07556497
- Acronym / sponsor ID
- 18-00008
- Conditions
- Diabete Type 2, Cardio Vascular Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Weill Cornell Medical College in QatarUniversity, hospital or other
- Collaborators
- Hamad Medical Corporation
- Study start
- 17 Nov 2020 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 29 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited from Hamad Medical Corporation.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
8 secondary outcomes
Expression levels of angiocrine factor genes in EPCs
Time frame: Following the EPC isolation (15-20 days)
Cytosolic calcium concetration in EPCs
Time frame: Following the EPC isolation (15-20 days)
Quantification of Mitochondrial reactive oxygen species (ROS) levels in EPCs
Time frame: Following the EPC isolation (15-20 days).
Protein Expression of Inflammatory Transcription Factors in Endothelial Progenitor Cells
Time frame: Following the EPC isolation (15 - 20 days).
Angiogenic Transcription Factor Expression in EPCs
Time frame: Time Frame: Following the EPC isolation (15 - 20 days).
Proportion of EPCs differentiating into endothelial cells in vitro
Time frame: 14 days after initiation of in vitro differentiation.
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.
Functional Outcomes of Genetically Enhanced Endothelial Progenitor Cells
Time frame: Following EPC isolation (15-20 days) and 72 hours post-gene transfection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: Undecided. ongoing discussion with the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Charbel Abi Khalil, MD,PhD principal investigator
Weill Cornell Medicine-Qatar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabete Type 2 and Cardio Vascular Disease, run by Weill Cornell Medical College in Qatar at 1 site in Qatar.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Qatar. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterization of EPCs dysregulation in Type 2 diabetes (time frame: Following the EPC isolation (15 - 20 days).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.