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NCT05597202
Does the Hematopoietic Stem Cell Govern Residual Inflammatory Cardiovascular Risk in Type 2 Diabetes
Conditions: Type 2 Diabetes
Sex: All
Ages: 50 Years – N/A
Phase: PHASE4
Enrollment: 22
Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Location: Netherlands
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.
Eligibility Criteria
Inclusion Criteria:Age >50 years oldDiagnosed with type 2 diabetesHbA1c >64mmol/molExclusion Criteria:(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.Chronic or recent infections and/or clinical signs of infection and/or a plasma C-reactive protein above 10ng/mlAuto-immune diseases (including type 1 diabetes)Recent or chronic immunosuppressant or antibiotic usageUse of any GLP1R-agonist at baseline or prior intolerance to use of GLP1R-agonists.Inability or unwillingness to comply with the protocol requirements, or deemed by investigator to be unfit for the study.Uncontrolled hypertension (systolic blood pressure > 180mmHg, diastolic blood pressure > 100mmHg)Uncontrolled chronic inflammatory conditions, including gout.Women of childbearing age who are not using effective contraceptives.Heart failure New York Heart Association (NYHA) class IV at screening visit.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.Pancreatitis in medical history.
Source: ClinicalTrials.gov (NCT05597202). StuddyBuddy aggregates publicly available trial information.