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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| metformin & acupuncture | Experimental | 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 & placebo | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| metformin | Drug | metformin tablet 500 mg |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amir Firouzjaei, Clinical PhD | Nanjing University of Traditional Chinese Medicine | Principal Investigator |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 acupuncture: Electro body acupuncture and auricular acupuncture |
| FG001 | 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 electro acupuncture (EA) machine was switched off during 30 minutes of therapeutic time. And ear acupuncture was just used sticky layers without seeds. All placebo treatments used for 30 minutes, 10 times, every other day, for 3 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
As a result, 39 participants were distributed by permuted-block randomization. 19 participants were assigned to the case group and 20 to the control group by an independent research assistant, and according to the above-mentioned method of randomization.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Patients between 20 and 65 years old of either gender |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | kg | baseline, week 3 |
|
3 WEEKS
All participants were treated 10 times every other day, for a total duration of 3 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 acupuncture: Electro body acupuncture and auricular acupuncture |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Amir Firouzjaei | Nanjing university of TCM | +989125397047 | amirfi@yahoo.com |
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| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D000529 |
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| acupuncture |
| Other |
Electro body acupuncture and auricular acupuncture |
|
| 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. | 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. | 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. | baseline, week 2, week 3 |
| Triglyceride (TG) | baseline, week 2, week 3 |
| Low Density Lipoprotein Cholesterol (LDLc) | 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. | 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. | 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. | 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. | 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. | 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. | 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. | baseline, week 2, week 3 |
| baseline, week 2, week 3 |
| BG001 |
| 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 |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 |
| 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 Placebo acupuncture including placebo EA and auricular acupuncture |
|
|
|
| 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. | Posted | Mean | Standard Deviation | mmol/L | baseline, week 2, week 3 |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | µIU/ml | baseline, week 2, week 3 |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | Pg/dl | baseline, week 2, week 3 |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | Pg/ml | baseline, week 2, week 3 |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | mg/dl | baseline, week 2, week 3 |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | mmol/L | baseline, week 2, week 3 |
|
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|
|
| Primary | Triglyceride (TG) | Posted | Mean | Standard Deviation | mmol/L | baseline, week 2, week 3 |
|
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|
|
| Primary | Low Density Lipoprotein Cholesterol (LDLc) | Posted | Mean | Standard Deviation | mmol/L | baseline, week 2, week 3 |
|
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|
| 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. | Posted | Mean | Standard Deviation | mmol/L | baseline, week 2, week 3 |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | g/dl | baseline, week 2, week 3 |
|
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|
|
| 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. | Posted | Mean | Standard Deviation | ng/ml | baseline, week 2, week 3 |
|
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|
|
| 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. | Posted | Mean | Standard Deviation | µg/ml | baseline, week 2, week 3 |
|
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| 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. | Posted | Mean | Standard Deviation | mmol/L | baseline, week 2, week 3 |
|
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| 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. | Posted | Mean | Standard Deviation | ng/ml | baseline, week 2, week 3 |
|
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|
|
| 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. | Posted | Mean | Standard Deviation | ng/ml | baseline, week 2, week 3 |
|
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| 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). | Posted | Mean | Standard Deviation | Kg/m² | baseline, week 3 |
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| 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. | Posted | Mean | Standard Deviation | units on a scale | baseline, week 2, week 3 |
|
|
|
|
| 0 |
| 19 |
| 0 |
| 19 |
| EG001 | 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 Placebo acupuncture including placebo EA and auricular acupuncture | 0 | 20 | 0 | 20 |
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| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Complementary Therapies |
| D013812 | Therapeutics |
| FBS blood concentration at the 3th sample, week 3 |
|
| FINS blood level at the 3th sample, week 3 |
|
| IL-6 blood level at the 3th sample, week 3 |
|
| TNF-α blood level at the 3th sample, week 3 |
|
| CRP blood level at the 3th sample, week 3 |
|
| 0.082 |
CRP is known to be an independent parameter |
| 2-Sided |
| 90 |
| Yes |
| Non-Inferiority or Equivalence |
from 0.60±0.03 mg/dl before treatment to 0.57±0.03 mg/dl after treatment, P=0.082 |
| ANOVA | 0.082 | CRP is known to be an independent parameter | 2-Sided | 90 | Yes | Non-Inferiority or Equivalence | from 0.59±0.03 mg/dl before treatment to 0.57±0.03 mg/dl after treatment, P=0.082 |
| FFAs blood level at the 3th sample, week 3 |
|
| TG blood level at the 3th sample, week 3 |
|
| LDLc blood level at the 3th sample, week 3 |
|
| HDLc blood level at the 3th sample, week 3 |
|
| ceramides blood level at the 3th sample, week 3 |
|
| Leptin blood level at the 3th sample, week 3 |
|
| Adiponectin blood level at the 3th sample, week 3 |
|
| GLP-1 blood level at the 3th sample, week 3 |
|
| Resistin blood level at the 3th sample, week 3 |
|
| Serotonin blood level at the 3th sample, week 3 |
|
| HOMA-IR at the 3th sample, week 3 |
|