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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
43
metformin tablet 500 mg
Electro body acupuncture and auricular acupuncture
Body Weight
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.
Time frame: baseline, week 3
Fasting Blood Sugar (FBS)
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.
Time frame: baseline, week 2, week 3
Fasting Insulin (FINS)
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.
Time frame: baseline, week 2, week 3
Interleukin-6 (IL-6)
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.
Time frame: baseline, week 2, week 3
Tumor Necrosis Factor-α (TNF-α)
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.
Time frame: baseline, week 2, week 3
C-reaction Protein (CRP)
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.
Time frame: baseline, week 2, week 3
Free Fatty Acids (FFAs)
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.
Time frame: baseline, week 2, week 3
Triglyceride (TG)
Time frame: baseline, week 2, week 3
Low Density Lipoprotein Cholesterol (LDLc)
Time frame: baseline, week 2, week 3
High Density Lipoprotein Cholesterol (HDLc)
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.
Time frame: baseline, week 2, week 3
Ceramides
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.
Time frame: baseline, week 2, week 3
Leptin
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.
Time frame: baseline, week 2, week 3
Adiponectin
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.
Time frame: baseline, week 2, week 3
Glucagon-like Peptide-1 (GLP-1)
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.
Time frame: baseline, week 2, week 3
Resistin
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.
Time frame: baseline, week 2, week 3
Serotonin
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.
Time frame: baseline, week 2, week 3
Body Mass Index (BMI)
change of BMI. Body height was measured to an accuracy of +/-0.1cm. BMI was calculated by dividing weight (kg) into height (squared m²).
Time frame: baseline, week 3
HOMA-IR
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.
Time frame: baseline, week 2, week 3
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