diabetes Diabetes mellitus type 2
Conditions
Interventions
Semaglutide s.c. once per week, for 6 months.
Dosage:
Month 1: 0.25mg
Month 2: 0.5mg
Month 3: 1.0mg
Month 4-6: 2.0mg
If the 2.0mg dose gives too many side effects, the highest tolerable dose will
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Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Age >50 years old - Diagnosed with type 2 diabetes - HbA1c >64mmol/mol
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -This study is designed to evaluate whether 68Ga-Dotatate uptake in the coronary arteries, in individuals with T2D can be reversed after 6 months of treatment with semaglutide up to a dose of 2.0mg once per week. -To investigate correlations between function and phenotype of bone marrow HSPCs in individuals with T2D and 68Ga-Dotatate uptake in the coronary arteries, aorta, bone marrow, and spleen. | — |
Secondary
| Measure | Time frame |
|---|---|
| - To compare function and phenotype of bone marrow HSPCs in individuals with T2D before and after treatment with semaglutide. - To evaluate whether 68Ga-Dotatate uptake in aorta, bone marrow, and spleen in individuals with T2D can be reversed after 6 months of treatment with up to 2.0mg semaglutide once per week. - To correlate the function and phenotype of HSPCs to glucose levels (as captured by HbA1c and continuous glucose monitoring) - To compare phenotype of HSPCs with phenotype of circulating monocytes in T2D patients on GLP1R-agonists. | — |
Countries
Netherlands
Outcome results
None listed