The effect of statin treatment on arterial wall inflammation in patients with diabetes mellitus as assessed with 68Ga-DOTATATE PET-CT

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 24

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

- 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 and/or CRP > 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.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter will be difference in arterial wall inflammation,<br /><br>expressed as target-to-background ratio (TBR) in the carotid, coronary arteries<br /><br>and aorta, after three months of statin therapy.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>We will assess any possible differences in systemic inflammatory state by<br /><br>measuring 68Ga-Dotatate uptake in spleen and bone-marrow.</p><br>