NL-OMON20201尚未招募不适用
The effect of statin treatment on arterial wall inflammation in patients with diabetesmeasured by 68Ga DOTATATE PET-CT
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- one
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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
- •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.
排除标准
- •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.
研究者
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