arterial wall thickening atherosclerosis
Conditions
Interventions
None listed
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients: 1. Aged 50 years and older 2. Diagnosed with diabetes mellitus type 2 and using oral glucose lowering therapy, insulin or combined glucose lowering therapy. 3. Not on statin therapy or willing to stop with current statin therapy for 6 weeks prior to visit 2. 4. HbA1c values below 65 mmol/L. 5. Patients with *stable* diabetes mellitus, i.e. no changes in type of glucose lowering therapy and / or dosage of oral glucose lowering therapy in the past three months. No more than 20% change in dosage of insulin therapy (short and long acting) in the last three months.
Exclusion criteria
Exclusion criteria: - History of cardiovascular disease (previous CV-event (MI / stroke) or known coronary artery disease (including acute coronary syndrome). - History of chronic kidney disease stage 3b - 5, defined as a CKD-EPI value of 10 mg/L. - History of auto-immune diseases. - Standard contra-indications to 68Ga-Dotatate PET, and CT based on physicians experience and current practices. - Inability or unwillingness to comply with the protocol requirements, or deemed by investigator to be unfit for the study. - Planned radiation exposure in the next year due to participation in a research project with radiation exposure or for clinical reasons. - Elevated liver enzymes (> 2 ULN of liver transaminases), acute liver failure or known liver disease. - Prior medium to severe statin-related side effects or statin related hypersensitivity, i.e. (severe) muscle pains with and/or without myopathy . - The concomitant use of statin contra-indicated drugs, including the use of CYP3A4 inhibitors (i.e. erytromycin, dilthiazem, amiodaron, verapamil, fluconazole, ciclosporin, stiripentol, itraconazol, ketoconazol, voriconazol, posaconazol, clarithromycin, ..), systemic use of fusidic acid and ciclosporin. - Any contra-indications to the use of statins.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameter will be difference in arterial wall inflammation, expressed as target-to-background ratio (TBR) in the carotid, coronary arteries and aorta, after three months of statin therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| We will assess any possible differences in systemic inflammatory state by measuring 68Ga-Dotatate uptake in spleen and bone-marrow. | — |
Countries
Netherlands
Outcome results
None listed