Evaluating the Effects of Electroacupuncture and Rosiglitazone Combined Therapy
2012年4月12日 更新者：China Medical University Hospital
A Randomized Controlled Trial Evaluating the Effects of Electroacupuncture and Rosiglitazone Combined Therapy on Patients With Type 2 Diabetes Mellitus
Aims: To evaluate the efficacy of rosiglitazone (TZD) and electroacupuncture (EA) combined therapy on patients with type 2 diabetes mellitus (T2DM). A randomized single-blind placebo controlled clinical trial was used.
Methods: A total of 31 newly diagnostic type 2 diabetic patients, who fulfilled the eligibility criteria were recruited and received various allocated interventions. They were randomly assigned into two groups, the control group (TZD, N=15) and the experimental group (TZD + EA, N=16). Changes in their plasma free fatty acid (FFA), glucose and insulin levels together with their homeostasis model assessment (HOMA) indices were statistically assessed between before and after treatment. Hypoglycemic activity (%) was also compared between these two groups.
Expecting Results: This study will compare the hypoglycemic activity and the ability of improving insulin resistance between the TZD and TZD+EA group. Also, the lowering effect of the plasma FFA concentration will be investigated.
研究概览
详细说明
This study is compared the effect between combined therapy (EA+TZD) and drug (TZD) on the patient of type 2 DM.
研究类型
介入性
注册 (实际的)
49
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Taichung、台湾、404
- Department of Integrative Chinese-Western Clinic, China Medical University Hospital
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
20年 至 65年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- all included native Taiwanese patients, age from 20 to 65 years who diagnosed with type 2 diabetes mellitus within 5 years and keep the same anti-hyperglycemic agents for control diabetes before and during the period in this study
- compatible with the diagnostic criteria of diabetes mellitus according to American Diabetes Association
Exclusion Criteria:
- individuals with nephrotic syndrome (urine protein over 3.5 g/day) and edema or renal failure (serum creatinine over 115 μmol/L)
- individuals who were diagnosed of heart failure (NYHA Fc III~IV) or pacemaker implantation
- individuals with abnormal liver function (GOT and GPT level above 2 folds of normal range) or diagnosis of liver cirrhosis
- individuals with higher HbA1C level (HbA1C above 9%)
- pregnant women
- individuals who were receiving the classes of drugs thiazolidinediones already
- individuals who were receiving insulin therapy already
- individuals who were receiving other therapy during the period of study
- individuals suffering a homeostasis disorder or other systemic disease
- individuals who did not comply with the treatment during the study period
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：EA + Rosiglitazone
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electroacupuncture and Rosiglitazone combined therapy on patient of type II DM
其他名称：
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安慰剂比较：Rosiglitazone
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Rosiglitazone 8 mg single dose
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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plasma glucose
大体时间：Time point(s) at which outcome measure is assessed in one year
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The primary endpoint with respect to plasma glucose level after treatment in each group of patients and compare the hypoglycemic activity between these two independent groups.
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Time point(s) at which outcome measure is assessed in one year
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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plasma free fatty acid (FFA)
大体时间：Time point(s) at which outcome measure is assessed in one year.
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This secondary endpoint will compare the percent change of plasma FFA level between these two independent groups.
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Time point(s) at which outcome measure is assessed in one year.
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plasma insulin
大体时间：Time point(s) at which outcome measure is assessed in one yease
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This secondary endpoint will compare the plasma insulin level after treatment of each group and the change between these two independent groups.
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Time point(s) at which outcome measure is assessed in one yease
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Shih-Liang Chang, PhD、China Medical University, China
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Pai HC, Tzeng CY, Lee YC, Chang CH, Lin JG, Cheng JT, Chang SL. Increase in plasma glucose lowering action of rosiglitazone by electroacupuncture at bilateral Zusanli acupoints (ST.36) in rats. J Acupunct Meridian Stud. 2009 Jun;2(2):147-51. doi: 10.1016/S2005-2901(09)60047-9.
- Lin RT, Pai HC, Lee YC, Tzeng CY, Chang CH, Hung PH, Chen YI, Hsu TH, Tsai CC, Lin JG, Chang SL. Electroacupuncture and rosiglitazone combined therapy as a means of treating insulin resistance and type 2 diabetes mellitus: a randomized controlled trial. Evid Based Complement Alternat Med. 2013;2013:969824. doi: 10.1155/2013/969824. Epub 2013 Jul 29.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2006年4月1日
初级完成 (实际的)
2007年5月1日
研究完成 (实际的)
2007年5月1日
研究注册日期
首次提交
2012年3月27日
首先提交符合 QC 标准的
2012年4月12日
首次发布 (估计)
2012年4月13日
研究记录更新
最后更新发布 (估计)
2012年4月13日
上次提交的符合 QC 标准的更新
2012年4月12日
最后验证
2012年4月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
EA + Rosiglitazone的临床试验
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Shijiazhuang Yiling Pharmaceutical Co. LtdFirst Affiliated Hospital, Sun Yat-Sen University邀请报名
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Zunyi Medical CollegeGuizhou Provincial People's Hospital; Binzhou Medical University; Union Hospital,Tong Ji Medical... 和其他合作者主动，不招人
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Kyunghee UniversityNational Rehabilitation Center, Seoul, Korea; Wonkwang University Gwangju Medical Center完全的
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National Institutes of Health Clinical Center (CC)招聘中
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National Institutes of Health Clinical Center (CC)招聘中
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Memorial Sloan Kettering Cancer Center招聘中