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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 主要终点
- C-reaction Protein (CRP)
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: metformin (Drug)
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.
干预措施: acupuncture (Other)
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.
干预措施: metformin (Drug)
结局指标
主要结局
C-reaction Protein (CRP)
时间窗: 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.
Triglyceride (TG)
时间窗: baseline, week 2, week 3
Low Density Lipoprotein Cholesterol (LDLc)
时间窗: baseline, week 2, week 3
Free Fatty Acids (FFAs)
时间窗: 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.
Fasting Blood Sugar (FBS)
时间窗: 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.
Body Weight
时间窗: 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.
Fasting Insulin (FINS)
时间窗: 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.
High Density Lipoprotein Cholesterol (HDLc)
时间窗: 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.
Ceramides
时间窗: 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.
Leptin
时间窗: 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.
Adiponectin
时间窗: 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.
Glucagon-like Peptide-1 (GLP-1)
时间窗: 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.
Interleukin-6 (IL-6)
时间窗: 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.
Resistin
时间窗: 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.
Serotonin
时间窗: 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.
Tumor Necrosis Factor-α (TNF-α)
时间窗: 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.
次要结局
- Body Mass Index (BMI)(baseline, week 3)
- HOMA-IR(baseline, week 2, week 3)
研究者
Amir Firouzjaei
Clinical PhD in Chinese medicine
Nanjing University of Traditional Chinese Medicine