NCT05730634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
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2019年6月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- DOTATATE coronary arteries
研究概览
简要总结
To study the effect of atorvastatin treatment on vascular uptake of 68Ga-DOTATATE in patients with Type 2 Diabetes.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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.
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.
- •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.
研究组 & 干预措施
Intervention arm
Experimental
Atorvastatin 40mg once daily.
干预措施: Atorvastatin 40 Mg Oral Tablet (Drug)
结局指标
主要结局
DOTATATE coronary arteries
时间窗: 3 months
Change in DOTATATE TBRmax coronary arteries after atorvastatin therapy
次要结局
- Change in splenic/bone marrow DOTATATE signal(3 month)
研究者
Nordin Hanssen
Dr.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
研究点 (1)
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