Role of Endothelial Progenitor Cells Dysregulation and Inflammation in the Pathophysiology of Cardiovascular Complications of Type 2 Diabetes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Diabete Type 2, Cardio Vascular Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Qatar
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Characterization of EPCs dysregulation in Type 2 diabetes [Time frame: Following the EPC isolation (15 - 20 days).]
- 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)]
Secondary outcome measures (8)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Qatar · 1 center
- Hamad Medical Corporation — Doha
Identifiers
NCT: NCT07556497 · 18-00008