A Randomized Controlled Trial Evaluating the Effects of Electroacupuncture and Rosiglitazone Combined Therapy on Patients With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- plasma glucose
研究概览
简要总结
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.
详细描述
This study is compared the effect between combined therapy (EA+TZD) and drug (TZD) on the patient of type 2 DM.
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
EA + Rosiglitazone
干预措施: EA + Rosiglitazone (Other)
Rosiglitazone
干预措施: TZD (Drug)
结局指标
主要结局
plasma glucose
时间窗: Time point(s) at which outcome measure is assessed in one year
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.
次要结局
- plasma free fatty acid (FFA)(Time point(s) at which outcome measure is assessed in one year.)
- plasma insulin(Time point(s) at which outcome measure is assessed in one yease)