The Effect of Statin Treatment on Arterial Wall Inflammation as Assessed With 68Ga-DOTATATE PET-CT

Well controlled patients with type 2 diabetes, who are statin naïve, will undergo atorvastatin treatment. Before and after treatment, patients will undergo a 68Ga-DOTATATE PET/CT, to evaluate the effect of treatment on vascular inflammation.

Inclusion criteria

• Aged 50 years and older
• Diagnosed with diabetes mellitus type 2 and using oral glucose lowering therapy, insulin or combined glucose lowering therapy.
• Not on statin therapy or willing to stop with current statin therapy for 6 weeks prior to visit 2.
• HbA1c values below 65 mmol/L.
• 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

• 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 < 45 ml/min/1,73m2
• 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 (< 1 month) infections and/or clinical signs of acute infection.
• 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.