EFFECT OF PARICALCITOL (ZEMPLAR) ON ENDOTHELIAL FUNCTION AND INFLAMMATION IN TYPE 2 DIABETES AND CHRONIC KIDNEY DISEASE
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- The change in brachial artery Flow Mediated Dilataion with paracalcitol (1mcg/day)compared with placebo for 3 months.
研究概览
简要总结
The purpose of this research study is to study the effects of paricalcitol on endothelial function and inflammation, cardiovascular risk factors which are associated with patient populations that have Type 2 diabetes and Stage 3 and 4 Chronic Kidney Disease (CKD).
Hypothesis 1: The state of CKD is associated with oxidative stress and inflammation and impaired post ischemic endothelium dependent flow mediated vasodilation which may contribute to atherogenesis.
Hypothesis 2: The administration of paracalcitol to patients with CKD will suppress oxidative stress and inflammation and improve endothelial function and thus contribute to an anti-atherogenic action.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Type 2 diabetes and CKD
- •Age 18 - 70 years
- •Stable anti-hypertensive and lipid lowering therapy for at least 2 months. All patients should be on an ACEI or ARB unless contraindicated because of side effects (standard of care). No changes in lipid lowering therapy during the 3 months of this study. Blood pressure doses may be changed but new therapy with ACE inhibitors will not be allowed.
排除标准
- •Severe co morbid conditions - e.g. Cancer, etc.
- •Congestive heart failure.
- •Inability to give informed consent or attend study related visits.
- •Have a history of abnormally high vitamin D or calcium levels in the bloodstream.
- •Unwilling or unable to complete screening or data collection procedures.
- •Have a known allergy to the study drug.
- •Pregnant or breast feeding
- •Plasma Calcium >9 mg/dl
- •Patients should discontinue any calcium supplementation prior to entry into the study.
- •Other vitamin D analogs (eg Sensipar) and vitamin D preparations are contraindicated
研究组 & 干预措施
Zemplar
Zemplar 1 mcg or placebo to be taken once daily with breakfast for 3 months
干预措施: Zemplar (Drug)
Placebo
Zemplar 1 mcg or placebo to be taken once daily with breakfast for 3 months
干预措施: Placebo (Drug)
结局指标
主要结局
The change in brachial artery Flow Mediated Dilataion with paracalcitol (1mcg/day)compared with placebo for 3 months.
时间窗: Baseline, 4 weeks, and 12 weeks
We therefore propose a study of the effects of Zemplar compared to placebo in patients with diabetes and stage 3-4 CKD on endothelial function and markers of inflammation and oxidative stress. The finding will help not only guide and encourage such treatment in similar patients, but will give us fundamental mechanistic insights into the role of vitamin D in the pathogenesis of diabetes and CVD.
次要结局
- Biomarker Measurement(Baseline, 4 weeks, and 12 weeks)
研究者
Vasudevan Raghavan
Director, CArdioMEtabolic, Lipid Clinic and Medical Weight Management Program Services
Scott and White Hospital & Clinic