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临床试验/NCT00745914
NCT00745914已完成不适用

A Randomized Placebo-Controlled Study to Evaluate the Efficacy of Peroxisome Proliferator-Activated Receptor-gamma (PPAR-gamma) Agonist in Inducing Carotid Atherosclerotic Plaque Regression in Diabetic End-Stage Renal Disease Patients

The University of Hong Kong2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2008年9月最近更新:
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
22
试验地点
2
主要终点
Change in carotid plaque volume

研究概览

简要总结

To test the hypothesis that PPAR-gamma agonist, rosiglitazone, induces carotid plaque regression in diabetic ESRD patients on maintenance PD via its anti-inflammatory property.

详细描述

End-stage renal disease (ESRD) patients are at an increased risk of accelerated atherosclerosis and cardiovascular morbidity and mortality. Non-traditional risk factors such as inflammation and insulin resistance have important contributions to accelerated atherosclerosis in ESRD patients receiving long-term peritoneal dialysis (PD). The peroxisome proliferator-activated receptor-g (PPAR-g) is a member of the nuclear receptor family of ligand-dependent transcription factors. Activation of the PPAR-g has been shown in both clinical and experimental studies to have anti-inflammatory and anti-atherosclerotic properties other than insulin-sensitizing effects. Recent study also showed that PPAR-g agonists reduce plaque inflammation by inhibiting the activation of proinflammatory genes responsible for plaque development and growth. Hence, this study aims to examine the effects of PPAR-g activation on the progression of carotid plaque in diabetic ESRD patients receiving long-term PD using high-resolution magnetic resonance imaging (MRI).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diabetic ESRD patients receiving long-term PD treatment, with carotid plaque (defined as focal intima-media thickening >1mm) present on screening ultrasonography
  • Patients who provide informed consent for the study

排除标准

  • Patients with systemic inflammatory disease such as systemic lupus erythematosus
  • Patients with chronic liver disease or cirrhosis
  • Patients with current active malignancy
  • Patients with chronic rheumatic heart disease or congenital heart disease
  • Patients with poor general condition
  • Patients with plan for living related kidney transplant within coming 1 year
  • Patients with pre-existing class III/IV heart failure,
  • Patients with recurrent hypoglycemia
  • Patients already on glitazone treatment
  • Female patients with pregnancy
  • Patients with contraindications for MRI examination including those with pacemaker or metallic implant.

研究组 & 干预措施

1

Experimental

Pioglitazone drug 15mg daily for 3 months then 30mg for 9 months (Peroxisome Proliferator-Activated Receptor-gamma agonist)

干预措施: Pioglitazone (Drug)

2

Placebo Comparator

placebo comparator drug 15mg daily for 3months, then 30mg for 9 months

干预措施: Placebo comparator (Drug)

结局指标

主要结局

Change in carotid plaque volume

时间窗: 12 months

次要结局

  • Change in inflammatory markers include C-reactive protein, interleukin-6, adiponectin, metalloproteinases(12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Angela Yee-Moon Wang

Dr

The University of Hong Kong

研究点 (2)

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