Insulin Sensitivity, Obesity
Conditions
Keywords
acupuncture, obesity, type 2 diabetic mellitus, insulin sensitivity, metformin, inflammatory factor, adipokines, lipid profile
Brief summary
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.
Detailed description
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
Interventions
DRUGmetformin
metformin tablet 500 mg
OTHERacupuncture
Electro body acupuncture and auricular acupuncture
Sponsors
Amir Firouzjaei
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serotonin | 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. |
| Glucagon-like Peptide-1 (GLP-1) | 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. |
| Resistin | 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. |
| Body Weight | 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 Blood Sugar (FBS) | 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. |
| Fasting Insulin (FINS) | 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. |
| Interleukin-6 (IL-6) | 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. |
| Tumor Necrosis Factor-α (TNF-α) | 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. |
| C-reaction Protein (CRP) | 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. |
| Free Fatty Acids (FFAs) | 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. |
| Triglyceride (TG) | baseline, week 2, week 3 | — |
| Low Density Lipoprotein Cholesterol (LDLc) | baseline, week 2, week 3 | — |
| High Density Lipoprotein Cholesterol (HDLc) | 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 | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HOMA-IR | 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. |
| Body Mass Index (BMI) | 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). |
Participant flow
Pre-assignment details
43 participants took part in trial. 4 of them were excluded from the trial according to including and excluding criteria. At last, 39 participants were distributed by permuted-block randomization.
Participants by arm
| Arm | Count |
|---|---|
| Metformin & Acupuncture Metformin 500 mg, to control their diabetes during the period of this study as previously (with different therapeutic dosage) and acupuncture treatment including electro body acupuncture and Auricular acupuncture for 30 minutes, 10 times, every other day, for 3 weeks.
metformin
acupuncture: Electro body acupuncture and auricular acupuncture | 19 |
| Metformin & Placebo Metformin 500 mg, to control their diabetes during the period of this study as previously (with different therapeutic dosage) and placebo ( for acupuncture treatment including electro body acupuncture and Auricular acupuncture), needling not in right acupoints (for those points that were located in the abdomen, needles were inserted 0.3 cm laterally from the real location and the needling was maximally superficial. Those points that were located on other parts of the body, needles were inserted 0.5 cm up and 0.5 cm laterally from the real location and needling was superficial as well. Electric lines were connected with some of the needles same way they were connected in another case group. EA machine was switched off during 30 minutes of therapeutic time. Ear acupuncture was used on the same location as in the case group however we just used sticky layers without seeds), for 30 minutes, 10 times, every other day, for 3 weeks.
metformin Placebo (for acupuncture including electro | 20 |
| Total | 39 |
Baseline characteristics
| Characteristic | Metformin & Acupuncture | Metformin & Placebo | Total |
|---|---|---|---|
| Age, Customized Mean age | 42.2 years STANDARD_DEVIATION 3.5 | 40.5 years STANDARD_DEVIATION 2.6 | 41.3 years STANDARD_DEVIATION 3 |
| Sex: Female, Male Female | 11 Participants | 12 Participants | 23 Participants |
| Sex: Female, Male Male | 8 Participants | 8 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 19 | 0 / 20 |
| serious Total, serious adverse events | 0 / 19 | 0 / 20 |
Outcome results
Primary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Metformin & Acupuncture | Adiponectin | Adiponectin blood level at the 3th sample, week 3 | 8.73 µg/ml | Standard Deviation 0.2 |
| Metformin & Acupuncture | Adiponectin | Adiponectin blood level at the baseline | 7.47 µg/ml | Standard Deviation 0.3 |
| Metformin & Acupuncture | Adiponectin | Adiponectin blood level at the 2th sample, week 2 | 8.26 µg/ml | Standard Deviation 0.2 |
| Metformin & Placebo | Adiponectin | Adiponectin blood level at the 3th sample, week 3 | 7.73 µg/ml | Standard Deviation 0.3 |
| Metformin & Placebo | Adiponectin | Adiponectin blood level at the baseline | 7.48 µg/ml | Standard Deviation 0.2 |
| Metformin & Placebo | Adiponectin | Adiponectin blood level at the 2th sample, week 2 | 7.58 µg/ml | Standard Deviation 0.3 |
p-value: <0.001ANOVA
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Metformin & Acupuncture | Body Weight | -4.1 kg | Standard Deviation 1.1 |
| Metformin & Placebo | Body Weight | -1.5 kg | Standard Deviation 0.3 |
p-value: <0.001ANOVA
Primary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Metformin & Acupuncture | Ceramides | ceramides blood level at the 1th sample, baseline | 8.06 g/dl | Standard Deviation 0.2 |
| Metformin & Acupuncture | Ceramides | ceramides blood level at the 2th sample, week 2 | 7.24 g/dl | Standard Deviation 0.3 |
| Metformin & Acupuncture | Ceramides | ceramides blood level at the 3th sample, week 3 | 6.06 g/dl | Standard Deviation 0.3 |
| Metformin & Placebo | Ceramides | ceramides blood level at the 1th sample, baseline | 7.92 g/dl | Standard Deviation 0.2 |
| Metformin & Placebo | Ceramides | ceramides blood level at the 2th sample, week 2 | 7.45 g/dl | Standard Deviation 0.2 |
| Metformin & Placebo | Ceramides | ceramides blood level at the 3th sample, week 3 | 7.18 g/dl | Standard Deviation 0.2 |
p-value: <0.001ANOVA
Primary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Metformin & Acupuncture | C-reaction Protein (CRP) | CRP blood level at the 1th sample, baseline | 0.60 mg/dl | Standard Deviation 0.03 |
| Metformin & Acupuncture | C-reaction Protein (CRP) | CRP blood level at the 2th sample, week 2 | 0.59 mg/dl | Standard Deviation 0.03 |
| Metformin & Acupuncture | C-reaction Protein (CRP) | CRP blood level at the 3th sample, week 3 | 0.57 mg/dl | Standard Deviation 0.03 |
| Metformin & Placebo | C-reaction Protein (CRP) | CRP blood level at the 1th sample, baseline | 0.59 mg/dl | Standard Deviation 0.03 |
| Metformin & Placebo | C-reaction Protein (CRP) | CRP blood level at the 2th sample, week 2 | 0.58 mg/dl | Standard Deviation 0.03 |
| Metformin & Placebo | C-reaction Protein (CRP) | CRP blood level at the 3th sample, week 3 | 0.57 mg/dl | Standard Deviation 0.03 |
p-value: 0.082ANOVA
p-value: 0.082ANOVA
p-value: 0.082ANOVA
Primary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Metformin & Acupuncture | Fasting Blood Sugar (FBS) | FBS blood concentration at the 3th sample, week 3 | 6.12 mmol/L | Standard Deviation 0.5 |
| Metformin & Acupuncture | Fasting Blood Sugar (FBS) | FBS blood concentration at the 1th sample, baselin | 6.65 mmol/L | Standard Deviation 0.6 |
| Metformin & Acupuncture | Fasting Blood Sugar (FBS) | FBS blood concentration at the 2th sample, week 2 | 6.44 mmol/L | Standard Deviation 0.5 |
| Metformin & Placebo | Fasting Blood Sugar (FBS) | FBS blood concentration at the 2th sample, week 2 | 6.55 mmol/L | Standard Deviation 0.5 |
| Metformin & Placebo | Fasting Blood Sugar (FBS) | FBS blood concentration at the 3th sample, week 3 | 6.54 mmol/L | Standard Deviation 0.5 |
| Metformin & Placebo | Fasting Blood Sugar (FBS) | FBS blood concentration at the 1th sample, baselin | 6.67 mmol/L | Standard Deviation 0.5 |
p-value: <0.001ANOVA
Primary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Metformin & Acupuncture | Fasting Insulin (FINS) | FINS blood level at the 1th sample, baseline | 14.47 µIU/ml | Standard Deviation 0.8 |
| Metformin & Acupuncture | Fasting Insulin (FINS) | FINS blood level at the 2th sample, week 2 | 12.92 µIU/ml | Standard Deviation 0.7 |
| Metformin & Acupuncture | Fasting Insulin (FINS) | FINS blood level at the 3th sample, week 3 | 9.91 µIU/ml | Standard Deviation 0.7 |
| Metformin & Placebo | Fasting Insulin (FINS) | FINS blood level at the 1th sample, baseline | 14.45 µIU/ml | Standard Deviation 0.7 |
| Metformin & Placebo | Fasting Insulin (FINS) | FINS blood level at the 2th sample, week 2 | 13.75 µIU/ml | Standard Deviation 0.7 |
| Metformin & Placebo | Fasting Insulin (FINS) | FINS blood level at the 3th sample, week 3 | 13.6 µIU/ml | Standard Deviation 0.8 |
p-value: <0.001ANOVA
Primary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Metformin & Acupuncture | Free Fatty Acids (FFAs) | FFAs blood level at the 1th sample, baseline | 0.72 mmol/L | Standard Deviation 0.04 |
| Metformin & Acupuncture | Free Fatty Acids (FFAs) | FFAs blood level at the 2th sample, week 2 | 0.61 mmol/L | Standard Deviation 0.03 |
| Metformin & Acupuncture | Free Fatty Acids (FFAs) | FFAs blood level at the 3th sample, week 3 | 0.51 mmol/L | Standard Deviation 0.03 |
| Metformin & Placebo | Free Fatty Acids (FFAs) | FFAs blood level at the 1th sample, baseline | 0.72 mmol/L | Standard Deviation 0.04 |
| Metformin & Placebo | Free Fatty Acids (FFAs) | FFAs blood level at the 2th sample, week 2 | 0.70 mmol/L | Standard Deviation 0 |
| Metformin & Placebo | Free Fatty Acids (FFAs) | FFAs blood level at the 3th sample, week 3 | 0.63 mmol/L | Standard Deviation 0.04 |
p-value: <0.001ANOVA
Primary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Metformin & Acupuncture | Glucagon-like Peptide-1 (GLP-1) | GLP-1 blood level at the 1th sample, baseline | 3.77 mmol/L | Standard Deviation 0.2 |
| Metformin & Acupuncture | Glucagon-like Peptide-1 (GLP-1) | GLP-1 blood level at the 2th sample, week 2 | 3.49 mmol/L | Standard Deviation 0.2 |
| Metformin & Acupuncture | Glucagon-like Peptide-1 (GLP-1) | GLP-1 blood level at the 3th sample, week 3 | 3.21 mmol/L | Standard Deviation 0.1 |
| Metformin & Placebo | Glucagon-like Peptide-1 (GLP-1) | GLP-1 blood level at the 1th sample, baseline | 3.75 mmol/L | Standard Deviation 0.2 |
| Metformin & Placebo | Glucagon-like Peptide-1 (GLP-1) | GLP-1 blood level at the 2th sample, week 2 | 3.50 mmol/L | Standard Deviation 0.2 |
| Metformin & Placebo | Glucagon-like Peptide-1 (GLP-1) | GLP-1 blood level at the 3th sample, week 3 | 3.43 mmol/L | Standard Deviation 0.2 |
p-value: <0.001ANOVA
Primary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Metformin & Acupuncture | High Density Lipoprotein Cholesterol (HDLc) | HDLc blood level at the 1th sample, baseline | 1.08 mmol/L | Standard Deviation 0.1 |
| Metformin & Acupuncture | High Density Lipoprotein Cholesterol (HDLc) | HDLc blood level at the 2th sample, week 2 | 1.20 mmol/L | Standard Deviation 0.1 |
| Metformin & Acupuncture | High Density Lipoprotein Cholesterol (HDLc) | HDLc blood level at the 3th sample, week 3 | 1.29 mmol/L | Standard Deviation 0.1 |
| Metformin & Placebo | High Density Lipoprotein Cholesterol (HDLc) | HDLc blood level at the 1th sample, baseline | 1.16 mmol/L | Standard Deviation 0.1 |
| Metformin & Placebo | High Density Lipoprotein Cholesterol (HDLc) | HDLc blood level at the 2th sample, week 2 | 1.21 mmol/L | Standard Deviation 0.1 |
| Metformin & Placebo | High Density Lipoprotein Cholesterol (HDLc) | HDLc blood level at the 3th sample, week 3 | 1.25 mmol/L | Standard Deviation 0.1 |
p-value: <0.001ANOVA
Primary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Metformin & Acupuncture | Interleukin-6 (IL-6) | IL-6 blood level at the 1th sample, baseline | 1.44 Pg/dl | Standard Deviation 0.03 |
| Metformin & Acupuncture | Interleukin-6 (IL-6) | IL-6 blood level at the 2th sample, week 2 | 1.30 Pg/dl | Standard Deviation 0.04 |
| Metformin & Acupuncture | Interleukin-6 (IL-6) | IL-6 blood level at the 3th sample, week 3 | 1.09 Pg/dl | Standard Deviation 0.05 |
| Metformin & Placebo | Interleukin-6 (IL-6) | IL-6 blood level at the 1th sample, baseline | 1.43 Pg/dl | Standard Deviation 0.02 |
| Metformin & Placebo | Interleukin-6 (IL-6) | IL-6 blood level at the 2th sample, week 2 | 1.41 Pg/dl | Standard Deviation 0.02 |
| Metformin & Placebo | Interleukin-6 (IL-6) | IL-6 blood level at the 3th sample, week 3 | 1.37 Pg/dl | Standard Deviation 0.04 |
p-value: <0.001ANOVA
Primary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Metformin & Acupuncture | Leptin | Leptin blood level at the 1th sample, baseline | 13.32 ng/ml | Standard Deviation 0.2 |
| Metformin & Acupuncture | Leptin | Leptin blood level at the 2th sample, week 2 | 11.58 ng/ml | Standard Deviation 0.4 |
| Metformin & Acupuncture | Leptin | Leptin blood level at the 3th sample, week 3 | 10.84 ng/ml | Standard Deviation 0.4 |
| Metformin & Placebo | Leptin | Leptin blood level at the 1th sample, baseline | 13.35 ng/ml | Standard Deviation 0.2 |
| Metformin & Placebo | Leptin | Leptin blood level at the 2th sample, week 2 | 12.67 ng/ml | Standard Deviation 0.4 |
| Metformin & Placebo | Leptin | Leptin blood level at the 3th sample, week 3 | 12.60 ng/ml | Standard Deviation 0.4 |
p-value: <0.001ANOVA
Primary
Low Density Lipoprotein Cholesterol (LDLc)
Time frame: baseline, week 2, week 3
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Metformin & Acupuncture | Low Density Lipoprotein Cholesterol (LDLc) | LDLc blood level at the 1th sample, baseline | 4.05 mmol/L | Standard Deviation 0.5 |
| Metformin & Acupuncture | Low Density Lipoprotein Cholesterol (LDLc) | LDLc blood level at the 2th sample, week 2 | 3.88 mmol/L | Standard Deviation 0.5 |
| Metformin & Acupuncture | Low Density Lipoprotein Cholesterol (LDLc) | LDLc blood level at the 3th sample, week 3 | 3.68 mmol/L | Standard Deviation 0.5 |
| Metformin & Placebo | Low Density Lipoprotein Cholesterol (LDLc) | LDLc blood level at the 1th sample, baseline | 4.08 mmol/L | Standard Deviation 0.5 |
| Metformin & Placebo | Low Density Lipoprotein Cholesterol (LDLc) | LDLc blood level at the 2th sample, week 2 | 4.0 mmol/L | Standard Deviation 0.5 |
| Metformin & Placebo | Low Density Lipoprotein Cholesterol (LDLc) | LDLc blood level at the 3th sample, week 3 | 3.95 mmol/L | Standard Deviation 0.5 |
p-value: <0.001ANOVA
Primary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Metformin & Acupuncture | Resistin | Resistin blood level at the 1th sample, baseline | 7.43 ng/ml | Standard Deviation 0.2 |
| Metformin & Acupuncture | Resistin | Resistin blood level at the 2th sample, week 2 | 6.34 ng/ml | Standard Deviation 0.3 |
| Metformin & Acupuncture | Resistin | Resistin blood level at the 3th sample, week 3 | 5.24 ng/ml | Standard Deviation 0.3 |
| Metformin & Placebo | Resistin | Resistin blood level at the 1th sample, baseline | 7.36 ng/ml | Standard Deviation 0.2 |
| Metformin & Placebo | Resistin | Resistin blood level at the 2th sample, week 2 | 6.76 ng/ml | Standard Deviation 0.2 |
| Metformin & Placebo | Resistin | Resistin blood level at the 3th sample, week 3 | 6.54 ng/ml | Standard Deviation 0.1 |
p-value: <0.001ANOVA
Primary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Metformin & Acupuncture | Serotonin | Serotonin blood level at the 1th sample, baseline | 130.4 ng/ml | Standard Deviation 3 |
| Metformin & Acupuncture | Serotonin | Serotonin blood level at the 2th sample, week 2 | 144.9 ng/ml | Standard Deviation 2 |
| Metformin & Acupuncture | Serotonin | Serotonin blood level at the 3th sample, week 3 | 170.5 ng/ml | Standard Deviation 3 |
| Metformin & Placebo | Serotonin | Serotonin blood level at the 1th sample, baseline | 128 ng/ml | Standard Deviation 2 |
| Metformin & Placebo | Serotonin | Serotonin blood level at the 2th sample, week 2 | 135.1 ng/ml | Standard Deviation 2 |
| Metformin & Placebo | Serotonin | Serotonin blood level at the 3th sample, week 3 | 147 ng/ml | Standard Deviation 3 |
p-value: <0.001ANOVA
Primary
Triglyceride (TG)
Time frame: baseline, week 2, week 3
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Metformin & Acupuncture | Triglyceride (TG) | TG blood level at the 1th sample, baseline | 2.59 mmol/L | Standard Deviation 0.6 |
| Metformin & Acupuncture | Triglyceride (TG) | TG blood level at the 2th sample, week 2 | 2.44 mmol/L | Standard Deviation 0.6 |
| Metformin & Acupuncture | Triglyceride (TG) | TG blood level at the 3th sample, week 3 | 2.24 mmol/L | Standard Deviation 0.5 |
| Metformin & Placebo | Triglyceride (TG) | TG blood level at the 1th sample, baseline | 2.69 mmol/L | Standard Deviation 0.7 |
| Metformin & Placebo | Triglyceride (TG) | TG blood level at the 2th sample, week 2 | 2.69 mmol/L | Standard Deviation 0.7 |
| Metformin & Placebo | Triglyceride (TG) | TG blood level at the 3th sample, week 3 | 2.65 mmol/L | Standard Deviation 0.7 |
p-value: <0.001ANOVA
Primary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Metformin & Acupuncture | Tumor Necrosis Factor-α (TNF-α) | TNF-α blood level at the 1th sample, baseline | 1.44 Pg/ml | Standard Deviation 0.02 |
| Metformin & Acupuncture | Tumor Necrosis Factor-α (TNF-α) | TNF-α blood level at the 2th sample, week 2 | 1.42 Pg/ml | Standard Deviation 0.04 |
| Metformin & Acupuncture | Tumor Necrosis Factor-α (TNF-α) | TNF-α blood level at the 3th sample, week 3 | 1.41 Pg/ml | Standard Deviation 0.05 |
| Metformin & Placebo | Tumor Necrosis Factor-α (TNF-α) | TNF-α blood level at the 1th sample, baseline | 1.44 Pg/ml | Standard Deviation 0.02 |
| Metformin & Placebo | Tumor Necrosis Factor-α (TNF-α) | TNF-α blood level at the 2th sample, week 2 | 1.43 Pg/ml | Standard Deviation 0.02 |
| Metformin & Placebo | Tumor Necrosis Factor-α (TNF-α) | TNF-α blood level at the 3th sample, week 3 | 1.43 Pg/ml | Standard Deviation 0.02 |
p-value: 0.04ANOVA
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Metformin & Acupuncture | Body Mass Index (BMI) | BMI blood level at the 1th sample, baseline | 27.6 Kg/m² | Standard Deviation 2.5 |
| Metformin & Acupuncture | Body Mass Index (BMI) | BMI blood level at the 3th sample, week 3 | 26.2 Kg/m² | Standard Deviation 2.4 |
| Metformin & Placebo | Body Mass Index (BMI) | BMI blood level at the 1th sample, baseline | 28.2 Kg/m² | Standard Deviation 1.6 |
| Metformin & Placebo | Body Mass Index (BMI) | BMI blood level at the 3th sample, week 3 | 27.7 Kg/m² | Standard Deviation 1.6 |
p-value: <0.001ANOVA
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Metformin & Acupuncture | HOMA-IR | HOMA-IR at the 3th sample, week 3 | 2.67 units on a scale | Standard Deviation 0.1 |
| Metformin & Acupuncture | HOMA-IR | HOMA-IR at the 1th sample, baseline | 4.25 units on a scale | Standard Deviation 0.2 |
| Metformin & Acupuncture | HOMA-IR | HOMA-IR at the 2th sample, week 2 | 3.68 units on a scale | Standard Deviation 0.1 |
| Metformin & Placebo | HOMA-IR | HOMA-IR at the 2th sample, week 2 | 4.06 units on a scale | Standard Deviation 0.5 |
| Metformin & Placebo | HOMA-IR | HOMA-IR at the 3th sample, week 3 | 4.01 units on a scale | Standard Deviation 0.5 |
| Metformin & Placebo | HOMA-IR | HOMA-IR at the 1th sample, baseline | 4.36 units on a scale | Standard Deviation 0.6 |
p-value: <0.001ANOVA