Does the hematopoietic stem cell govern residual inflammatory cardiovascular risk in type 2 diabetes?

Recruiting

• Conditions: diabetes; Diabetes mellitus type 2; 10011082; 10012653

• Registration Number: NL-OMON53529
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 22

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>-This study is designed to evaluate whether 68Ga-Dotatate uptake in the<br /><br>coronary arteries, in individuals with T2D can be reversed after 6 months of<br /><br>treatment with semaglutide up to a dose of 2.0mg once per week.<br /><br>-To investigate correlations between function and phenotype of bone marrow<br /><br>HSPCs in individuals with T2D and 68Ga-Dotatate uptake in the coronary<br /><br>arteries, aorta, bone marrow, and spleen. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- To compare function and phenotype of bone marrow HSPCs in individuals with<br /><br>T2D before and after treatment with semaglutide.<br /><br>- To evaluate whether 68Ga-Dotatate uptake in aorta, bone marrow, and spleen in<br /><br>individuals with T2D can be reversed after 6 months of treatment with up to<br /><br>2.0mg semaglutide once per week.<br /><br>- To correlate the function and phenotype of HSPCs to glucose levels (as<br /><br>captured by HbA1c and continuous glucose monitoring)<br /><br>- To compare phenotype of HSPCs with phenotype of circulating monocytes in T2D<br /><br>patients on GLP1R-agonists.</p><br>