The effect of statin treatment on arterial wall inflammation in patients with diabetesmeasured by 68Ga DOTATATE PET-CT
- Conditions
- Diabetes mellitus type 2
- Registration Number
- NL-OMON20201
- Lead Sponsor
- one
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 24
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.(22)
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.
1. History of cardiovascular disease (previous CV-event (MI / stroke) or known coronary
artery disease (including acute coronary syndrome).
2. History of chronic kidney disease stage 3b - 5, defined as a CKD-EPI value of < 45
ml/min/1,73m2
.
3. Malignant diseases or any clinically significant medical condition that could interfere
with the conduct of the study in the opinion of the investigator.
4. Chronic or recent (< 1 month) infections and/or clinical signs of acute infection.
5. History of auto-immune diseases.
6. Standard contra-indications to 68Ga-Dotatate PET, and CT based on physicians
experience and current practices.
7. Inability or unwillingness to comply with the protocol requirements, or deemed by
investigator to be unfit for the study.
8. Planned radiation exposure in the next year due to participation in a research project
with radiation exposure or for clinical reasons.
9. Elevated liver enzymes (> 2 ULN of liver transaminases), acute liver failure or known
liver disease.
10. Prior medium to severe statin-related side effects or statin related hypersensitivity, i.e.
(severe) muscle pains with and/or without myopathy .
11. 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.
12. Any contra-indications to the use of statins.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The main objective of this study is to assess the extent of increased wall<br>inflammation of patients with diabetes mellitus type-2 with 68Ga-Dotatate PET-CT<br>and to assess the difference in 68Ga-Dotatate arterial wall inflammation after three<br>months of atorvastatin 40mg therapy.<br>• The main study parameter will be the 68Ga-Dotatate uptake, expressed as targetto-background ratio (TBR) in the carotid arteries and aorta.
- Secondary Outcome Measures
Name Time Method The secondary objective of this study is to assess the feasibility to measure splenic<br>and bone-marrow inflammatory activity with 68Ga-Dotatate PET-CT in patients with<br>diabetes mellitus, expressed as the target-to-background ratio (TBR)