NL-OMON55746已完成不适用
The effect of statin treatment on arterial wall inflammation in patients with diabetes mellitus as assessed with 68Ga-DOTATATE PET-CT - CARAME
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 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
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
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 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.
排除标准
- •- 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.
研究者
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