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

Study Overview
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Brief Summary
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To study the effect of atorvastatin treatment on vascular uptake of 68Ga-DOTATATE in patients with Type 2 Diabetes.

Detailed Description
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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.

Official Title
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The Effect of Statin Treatment on Arterial Wall Inflammation in Patients With Diabetes Mellitus as Assessed With 68Ga-DOTATATE PET-CT

Conditions
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Diabetes Mellitus, Type 2, Vascular Inflammation

Intervention / Treatment
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* Drug: Atorvastatin 40 Mg Oral Tablet


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention arm<br>Atorvastatin 40mg once daily. | Drug: Atorvastatin 40 Mg Oral Tablet<br>* Atorvastatin 40mg once daily for three months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DOTATATE coronary arteries | Change in DOTATATE TBRmax coronary arteries after atorvastatin therapy | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in splenic/bone marrow DOTATATE signal | The secondary objective of this study is to assess the feasibility to measure splenic and bone-marrow inflammatory activity with 68Ga-Dotatate PET-CT in patients with diabetes mellitus, expressed as SUVmax | 3 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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statin, dotatate, vascular inflammation, type 2 diabetes mellitus, pet/ct, positron emmission tomography