Comparative the Effect of Metformin and Acupuncture on Weight Loss and Insulin Sensitivity
2016年10月14日 更新者：Amir Firouzjaei
Placebo-controlled, Randomized, Double Blind Trial, What is the Therapeutic Effect of Metformin and Acupuncture Combined Therapy in Comparison With Metformin Monotherapy on Weight Loss and Insulin Sensitivity in Diabetic Patients
The investigators designed this randomized double blind (patients/ assessor) clinical trial to compare the therapeutic effects of Metformin monotherapy with Metformin and acupuncture combined therapy on weight loss and insulin sensitivity among overweight/obese type 2 diabetes mellitus (T2DM) patients.
We compared the inflammatory markers, lipid profiles, and adipokines in overweight/obese T2DM patients receiving the combined therapy to those receiving the Metformin monotherapy, to understand whether acupuncture plus Metformin is a better approach then Metformin only on treating diabetes.
研究概览
详细说明
From 39 participants, 19 participants were sent to case group and 20 to control group according to above mentioned method of randomization by independent research assistant.
In the case group enrolled participants were treated with Metformin monotherapy and received electro acupuncture (EA) and Auricular acupuncture at the selected acupoints, and participants in a control group were treated with Metformin monotherapy and received sham EA.
All patients were blinded to treatment assignment during the period of study and assessor was blinded to name of the patients and results as well.
IR was calculated by the homeostasis model assessment of insulin resistance (HOMA-IR) proposed by Matthews et al.
HOMA-IR = (fasting insulin (mmol/L) × fasting glucose (µIU/ml))/22.5;
body height was measured to an accuracy of +/-0.1cm;
body weight was measured while the subjects were dressed in light clothing after an overnight fasting by standard scale to an accuracy of +/-0.1 kg; The body mass index (BMI) was calculated by dividing weight (kg) into height (squared m²).
Blood markers including fasting blood sugar (FBS), fasting insulin (FINS), interleukin-6 (IL-6), tumor necrosis α (TNFα), C reactive protein (CRP), leptin, adiponectin, resistin, glucagon-like peptide-1 (GLP-1), HOMA index , free fatty acid (FFAs), low density lipoprotein cholesterol (LDLc), high density lipoprotein cholesterol (HDLc) , and ceramides; were calculated by measuring them after drawing 10 ml of blood from cubital vein in each patient after 8 hours overnight fasting, before treatment, and for FBS, FINS and HOMA index 30 min after treatment additionally, 3 times during the study (in the beginning, in the 5th time and at the end) from both groups, with the chosen for this research standard range.
All data with standard range were managed by Epi-data software, then analyzed by Statistical Package for the Social Sciences (SPSS) software 15.0.0 (6 Sep 2006).
The investigators statistics method included T-test and repeated measures ANOVA.
P-Value<0.05
was statistically significant in this trial
研究类型
介入性
注册 (实际的)
43
阶段
- 不适用
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:
- Who had been diagnosed with type 2 diabetes mellitus and has using Metformin monotherapy as well to control their diabetes during the period of this study as previously (500 mg one/two/three times per day)
- All patients were overweight according to BMI ≥25
Exclusion Criteria:
- Individuals with nephritic syndrome (urine protein over 3.5 g/day), edema or renal failure (serum creatinine over 115 µmol/L)
- Individuals who had been diagnosed with heart failure (NYHA Fc III-IV) or who had been a pacemaker implanted
- Individuals with abnormal liver dysfunction (GOT and glutamate-pyruvate transaminase (GPT) levels twofold above the normal range) or a diagnosis of liver cirrhosis
- Individuals with a high HbA1C level (HbA1C above 9 %)
- Pregnant women
- Individuals who were receiving insulin therapy already
- Individuals who receive other therapy or had any change at dosage during the period of therapy
- Individuals who were suffering from endocrine abnormalities such as Thyroid disease, polycystic ovary syndrome (PCOS), etc
- Individuals who were receiving weight loss medicine, anti depressant agents' or hormonal medicines during the last 3 months and the period of study
- Individuals who were suffering from a homeostasis disorder or other systemic disease
- Individuals who did not comply(signed informed consent) 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：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：metformin & acupuncture
Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and acupuncture treatment including electro body acupuncture and Auricular acupuncture for 30 minutes, 10 times, every other day, for 3 weeks.
|
metformin tablet 500 mg
Electro body acupuncture and auricular acupuncture
|
|
安慰剂比较：metformin & placebo
Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and placebo acupuncture treatment, needling not in right acupoints and EA machine was switched off during 30 minutes of therapeutic time.
For ear acupuncture was just used sticky layers without seeds.
All placebo treatment used for 30 minutes, 10 times, every other day, for 3 weeks.
|
metformin tablet 500 mg
|
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 |
|---|---|---|
|
Body Weight
大体时间：baseline, week 3
|
The effect of Metformin and acupuncture combined therapy on weight loss (Change from baseline in body weight), body weight was measured while the subjects were dressed in light clothing after an overnight fasting and by a standard scale to an accuracy of +/-0.1 kg.
All measures were recorded by one assessment, at baseline before the first time treatment, and before the last time treatment at week 3.
|
baseline, week 3
|
|
Fasting Blood Sugar (FBS)
大体时间：baseline, week 2, week 3
|
changes FBS, Blood markers were calculated by measuring them after drawing 10 ml of blood from cubital vein in each patient, after 8 hours of overnight fasting and before treatment; Blood was collected three times during the study (at the beginning, at the 5th time, and at the end), from groups, using standard range and ELISA diagnostic kits (Biomatik USA LLC, www.biomatik.com),
and clinical assessments and measurements undertaken after 3 weeks.
Readings/assessment was performed at 3 weeks.
|
baseline, week 2, week 3
|
|
Fasting Insulin (FINS)
大体时间：baseline, week 2, week 3
|
change of FINS,Blood markers were calculated by measuring them after drawing 10 ml of blood from cubital vein in each patient, after 8 hours of overnight fasting and before treatment; Blood was collected three times during the study (at the beginning, at the 5th time, and at the end), from groups, using standard range and ELISA diagnostic kits (Biomatik USA LLC, www.biomatik.com),
and clinical assessments and measurements undertaken after 3 weeks.
Readings/assessment was performed at 3 weeks.
|
baseline, week 2, week 3
|
|
Interleukin-6 (IL-6)
大体时间：baseline, week 2, week 3
|
IL-6 changes, IL-6 were calculated by measuring them after drawing 10 ml of blood from cubital vein in each patient, after 8 hours of overnight fasting and before treatment; Blood was collected three times during the study (at the beginning, at the 5th time, and at the end), from groups, using standard range and ELISA diagnostic kits (Biomatik USA LLC, www.biomatik.com),
and clinical assessments and measurements undertaken after 3 weeks.
Readings/assessment was performed at 3 weeks.
|
baseline, week 2, week 3
|
|
Tumor Necrosis Factor-α (TNF-α)
大体时间：baseline, week 2, week 3
|
Blood markers changes in TNF α, were calculated by measuring them after drawing 10 ml of blood from cubital vein in each patient, after 8 hours of overnight fasting and before treatment; Blood was collected three times during the study (at the beginning, at the 5th time, and at the end), from groups, using standard range and ELISA diagnostic kits (Biomatik USA LLC, www.biomatik.com),
and clinical assessments and measurements undertaken after 3 weeks.
Readings/assessment was performed at 3 weeks.
|
baseline, week 2, week 3
|
|
C-reaction Protein (CRP)
大体时间：baseline, week 2, week 3
|
CRP blood markers changes; Blood markers were calculated by measuring them after drawing 10 ml of blood from cubital vein in each patient, after 8 hours of overnight fasting and before treatment; Blood was collected three times during the study (at the beginning, at the 5th time, and at the end), from groups, using standard range and ELISA diagnostic kits (Biomatik USA LLC, www.biomatik.com),
and clinical assessments and measurements undertaken after 3 weeks.
Readings/assessment was performed at 3 weeks.
|
baseline, week 2, week 3
|
|
Free Fatty Acids (FFAs)
大体时间：baseline, week 2, week 3
|
Blood markers were calculated by measuring them after drawing 10 ml of blood from cubital vein in each patient, after 8 hours of overnight fasting and before treatment; Blood was collected three times during the study (at the beginning, at the 5th time, and at the end), from groups, using standard range and ELISA diagnostic kits (Biomatik USA LLC, www.biomatik.com),
and clinical assessments and measurements undertaken after 3 weeks.
Readings/assessment was performed at 3 weeks.
|
baseline, week 2, week 3
|
|
Triglyceride (TG)
大体时间：baseline, week 2, week 3
|
baseline, week 2, week 3
|
|
|
Low Density Lipoprotein Cholesterol (LDLc)
大体时间：baseline, week 2, week 3
|
baseline, week 2, week 3
|
|
|
High Density Lipoprotein Cholesterol (HDLc)
大体时间：baseline, week 2, week 3
|
HDLc changes, Blood markers were calculated by measuring them after drawing 10 ml of blood from cubital vein in each patient, after 8 hours of overnight fasting and before treatment; Blood was collected three times during the study (at the beginning, at the 5th time, and at the end), from groups, using standard range and ELISA diagnostic kits (Biomatik USA LLC, www.biomatik.com),
and clinical assessments and measurements undertaken after 3 weeks.
Readings/assessment was performed at 3 weeks.
|
baseline, week 2, week 3
|
|
Ceramides
大体时间：baseline, week 2, week 3
|
Changes in ceramides blood level, Blood markers were calculated by measuring them after drawing 10 ml of blood from cubital vein in each patient, after 8 hours of overnight fasting and before treatment; Blood was collected three times during the study (at the beginning, at the 5th time, and at the end), from groups, using standard range and ELISA diagnostic kits (Biomatik USA LLC, www.biomatik.com),
and clinical assessments and measurements undertaken after 3 weeks.
Readings/assessment was performed at 3 weeks.
|
baseline, week 2, week 3
|
|
Leptin
大体时间：baseline, week 2, week 3
|
changes in Leptin blood level, Blood markers were calculated by measuring them after drawing 10 ml of blood from cubital vein in each patient, after 8 hours of overnight fasting and before treatment; Blood was collected three times during the study (at the beginning, at the 5th time, and at the end), from groups, using standard range and ELISA diagnostic kits (Biomatik USA LLC, www.biomatik.com),
and clinical assessments and measurements undertaken after 3 weeks.
Readings/assessment was performed at 3 weeks.
|
baseline, week 2, week 3
|
|
Adiponectin
大体时间：baseline, week 2, week 3
|
Changes in Adiponectin blood level, Blood markers were calculated by measuring them after drawing 10 ml of blood from cubital vein in each patient, after 8 hours of overnight fasting and before treatment; Blood was collected three times during the study (at the beginning, at the 5th time, and at the end), from groups, using standard range and ELISA diagnostic kits (Biomatik USA LLC, www.biomatik.com),
and clinical assessments and measurements undertaken after 3 weeks.
Readings/assessment was performed at 3 weeks.
|
baseline, week 2, week 3
|
|
Glucagon-like Peptide-1 (GLP-1)
大体时间：baseline, week 2, week 3
|
changes in GLP-1 blood level, Blood markers were calculated by measuring them after drawing 10 ml of blood from cubital vein in each patient, after 8 hours of overnight fasting and before treatment; Blood was collected three times during the study (at the beginning, at the 5th time, and at the end), from groups, using standard range and ELISA diagnostic kits (Biomatik USA LLC, www.biomatik.com),
and clinical assessments and measurements undertaken after 3 weeks.
Readings/assessment was performed at 3 weeks.
|
baseline, week 2, week 3
|
|
Resistin
大体时间：baseline, week 2, week 3
|
Changes in Resistin blood level, Blood markers were calculated by measuring them after drawing 10 ml of blood from cubital vein in each patient, after 8 hours of overnight fasting and before treatment; Blood was collected three times during the study (at the beginning, at the 5th time, and at the end), from groups, using standard range and ELISA diagnostic kits (Biomatik USA LLC, www.biomatik.com),
and clinical assessments and measurements undertaken after 3 weeks.
Readings/assessment was performed at 3 weeks.
|
baseline, week 2, week 3
|
|
Serotonin
大体时间：baseline, week 2, week 3
|
changes in Serotonin blood level, Blood markers were calculated by measuring them after drawing 10 ml of blood from cubital vein in each patient, after 8 hours of overnight fasting and before treatment; Blood was collected three times during the study (at the beginning, at the 5th time, and at the end), from groups, using standard range and ELISA diagnostic kits (Biomatik USA LLC, www.biomatik.com),
and clinical assessments and measurements undertaken after 3 weeks.
Readings/assessment was performed at 3 weeks.
|
baseline, week 2, week 3
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Body Mass Index (BMI)
大体时间：baseline, week 3
|
change of BMI.
Body height was measured to an accuracy of +/-0.1cm.
BMI was calculated by dividing weight (kg) into height (squared m²).
|
baseline, week 3
|
|
HOMA-IR
大体时间：baseline, week 2, week 3
|
Changes of IR was calculated by the homeostasis model (HOMA-IR), proposed by Matthews et al.
HOMA-IR = (fasting insulin (mmol/L) × fasting glucose (µIU/ml))/22•5.
Blood markers were calculated by measuring them after drawing 10 ml of blood from cubital vein in each patient, after 8 hours of overnight fasting and before treatment; Blood was collected three times during the study (at the beginning, at the 5th time, and at the end), from groups, using standard range and ELISA diagnostic kits (Biomatik USA LLC, www.biomatik.com),
and clinical assessments and measurements undertaken after 3 weeks.
Readings/assessment was performed at 3 weeks.
|
baseline, week 2, week 3
|
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：Amir Firouzjaei, Clinical PhD、Nanjing University of Traditional Chinese Medicine
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
2014年5月1日
初级完成 (实际的)
2015年1月1日
研究完成 (实际的)
2015年4月1日
研究注册日期
首次提交
2015年4月21日
首先提交符合 QC 标准的
2015年5月5日
首次发布 (估计)
2015年5月8日
研究记录更新
最后更新发布 (估计)
2016年12月8日
上次提交的符合 QC 标准的更新
2016年10月14日
最后验证
2016年10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.
metformin的临床试验
-
Poznan University of Medical SciencesUniversity of California, San Diego未知
-
Boehringer IngelheimEli Lilly and Company完全的
-
Boehringer IngelheimEli Lilly and Company完全的