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
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
- 否
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
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 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
Dr. Angela Yee-Moon Wang
Dr
The University of Hong Kong
