Does the Hematopoietic Stem Cell Govern Residual Inflammatory Cardiovascular Risk in Type 2 Diabetes

• Status: Not yet recruiting
• Trial end date: 2024-04-01
• Target enrollment: 0
• Participant gender: All

Summary

To study the effect of type 2 diabetes (T2D) on vascular wall inflammation and hematopoietic stem cell composition in vivo, and whether these changes can be reversed with glucagon like peptide 1 receptor (GLP1R)-agonism.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Collaborator: Dutch Heart Foundation

Criteria

Inclusion Criteria:

• Age >50 years old

• Diagnosed with type 2 diabetes

• HbA1c >64mmol/mol

Exclusion Criteria:

1. (History of) malignant diseases or any clinically significant medical condition that could interfere with the conduct of the study in the opinion of the investigator.

2. Chronic or recent infections and/or clinical signs of infection and/or a plasma C-reactive protein above 10ng/ml

3. Auto-immune diseases (including type 1 diabetes)

4. Recent or chronic immunosuppressant or antibiotic usage

5. Use of any GLP1R-agonist at baseline or prior intolerance to use of GLP1R-agonists.

6. Inability or unwillingness to comply with the protocol requirements, or deemed by investigator to be unfit for the study.

7. Uncontrolled hypertension (systolic blood pressure > 180mmHg, diastolic blood pressure > 100mmHg)

8. Uncontrolled chronic inflammatory conditions, including gout.

9. Women of childbearing age who are not using effective contraceptives.

10. Heart failure New York Heart Association (NYHA) class IV at screening visit.

11. Active liver disease or hepatic dysfunction, defined as aspartate aminotransferase (ASAT) or alanine aminotransferase (ALAT) ≥ 2 times the upper limit of normal (ULN) at screening visit.

12. Pancreatitis in medical history.