Trial Outcomes & Findings for Comparative the Effect of Metformin and Acupuncture on Weight Loss and Insulin Sensitivity (NCT NCT02438540)
NCT ID: NCT02438540
Last Updated: 2016-12-08
Results Overview
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.
COMPLETED
NA
43 participants
baseline, week 3
2016-12-08
Participant Flow
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.
Participant milestones
| Measure |
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
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
20
|
|
Overall Study
COMPLETED
|
19
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparative the Effect of Metformin and Acupuncture on Weight Loss and Insulin Sensitivity
Baseline characteristics by cohort
| Measure |
Metformin & Acupuncture
n=19 Participants
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
|
Metformin & Placebo
n=20 Participants
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
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Mean age
|
42.2 years
STANDARD_DEVIATION 3.5 • n=5 Participants
|
40.5 years
STANDARD_DEVIATION 2.6 • n=7 Participants
|
41.3 years
STANDARD_DEVIATION 3.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline, week 3The 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.
Outcome measures
| Measure |
Metformin & Acupuncture
n=19 Participants
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
|
Metformin & Placebo
n=20 Participants
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
|
|---|---|---|
|
Body Weight
|
-4.1 kg
Standard Deviation 1.1
|
-1.5 kg
Standard Deviation 0.3
|
PRIMARY outcome
Timeframe: baseline, week 2, week 3changes 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.
Outcome measures
| Measure |
Metformin & Acupuncture
n=19 Participants
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
|
Metformin & Placebo
n=20 Participants
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
|
|---|---|---|
|
Fasting Blood Sugar (FBS)
FBS blood concentration at the 2th sample, week 2
|
6.44 mmol/L
Standard Deviation 0.5
|
6.55 mmol/L
Standard Deviation 0.5
|
|
Fasting Blood Sugar (FBS)
FBS blood concentration at the 3th sample, week 3
|
6.12 mmol/L
Standard Deviation 0.5
|
6.54 mmol/L
Standard Deviation 0.5
|
|
Fasting Blood Sugar (FBS)
FBS blood concentration at the 1th sample, baselin
|
6.65 mmol/L
Standard Deviation 0.6
|
6.67 mmol/L
Standard Deviation 0.5
|
PRIMARY outcome
Timeframe: baseline, week 2, week 3change 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.
Outcome measures
| Measure |
Metformin & Acupuncture
n=19 Participants
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
|
Metformin & Placebo
n=20 Participants
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
|
|---|---|---|
|
Fasting Insulin (FINS)
FINS blood level at the 1th sample, baseline
|
14.47 µIU/ml
Standard Deviation 0.8
|
14.45 µIU/ml
Standard Deviation 0.7
|
|
Fasting Insulin (FINS)
FINS blood level at the 2th sample, week 2
|
12.92 µIU/ml
Standard Deviation 0.7
|
13.75 µIU/ml
Standard Deviation 0.7
|
|
Fasting Insulin (FINS)
FINS blood level at the 3th sample, week 3
|
9.91 µIU/ml
Standard Deviation 0.7
|
13.6 µIU/ml
Standard Deviation 0.8
|
PRIMARY outcome
Timeframe: baseline, week 2, week 3IL-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.
Outcome measures
| Measure |
Metformin & Acupuncture
n=19 Participants
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
|
Metformin & Placebo
n=20 Participants
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
|
|---|---|---|
|
Interleukin-6 (IL-6)
IL-6 blood level at the 1th sample, baseline
|
1.44 Pg/dl
Standard Deviation 0.03
|
1.43 Pg/dl
Standard Deviation 0.02
|
|
Interleukin-6 (IL-6)
IL-6 blood level at the 2th sample, week 2
|
1.30 Pg/dl
Standard Deviation 0.04
|
1.41 Pg/dl
Standard Deviation 0.02
|
|
Interleukin-6 (IL-6)
IL-6 blood level at the 3th sample, week 3
|
1.09 Pg/dl
Standard Deviation 0.05
|
1.37 Pg/dl
Standard Deviation 0.04
|
PRIMARY outcome
Timeframe: baseline, week 2, week 3Blood 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.
Outcome measures
| Measure |
Metformin & Acupuncture
n=19 Participants
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
|
Metformin & Placebo
n=20 Participants
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
|
|---|---|---|
|
Tumor Necrosis Factor-α (TNF-α)
TNF-α blood level at the 1th sample, baseline
|
1.44 Pg/ml
Standard Deviation 0.02
|
1.44 Pg/ml
Standard Deviation 0.02
|
|
Tumor Necrosis Factor-α (TNF-α)
TNF-α blood level at the 2th sample, week 2
|
1.42 Pg/ml
Standard Deviation 0.04
|
1.43 Pg/ml
Standard Deviation 0.02
|
|
Tumor Necrosis Factor-α (TNF-α)
TNF-α blood level at the 3th sample, week 3
|
1.41 Pg/ml
Standard Deviation 0.05
|
1.43 Pg/ml
Standard Deviation 0.02
|
PRIMARY outcome
Timeframe: baseline, week 2, week 3CRP 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.
Outcome measures
| Measure |
Metformin & Acupuncture
n=19 Participants
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
|
Metformin & Placebo
n=20 Participants
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
|
|---|---|---|
|
C-reaction Protein (CRP)
CRP blood level at the 1th sample, baseline
|
0.60 mg/dl
Standard Deviation 0.03
|
0.59 mg/dl
Standard Deviation 0.03
|
|
C-reaction Protein (CRP)
CRP blood level at the 2th sample, week 2
|
0.59 mg/dl
Standard Deviation 0.03
|
0.58 mg/dl
Standard Deviation 0.03
|
|
C-reaction Protein (CRP)
CRP blood level at the 3th sample, week 3
|
0.57 mg/dl
Standard Deviation 0.03
|
0.57 mg/dl
Standard Deviation 0.03
|
PRIMARY outcome
Timeframe: baseline, week 2, week 3Blood 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.
Outcome measures
| Measure |
Metformin & Acupuncture
n=19 Participants
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
|
Metformin & Placebo
n=20 Participants
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
|
|---|---|---|
|
Free Fatty Acids (FFAs)
FFAs blood level at the 1th sample, baseline
|
0.72 mmol/L
Standard Deviation 0.04
|
0.72 mmol/L
Standard Deviation 0.04
|
|
Free Fatty Acids (FFAs)
FFAs blood level at the 2th sample, week 2
|
0.61 mmol/L
Standard Deviation 0.03
|
0.70 mmol/L
Standard Deviation 0
|
|
Free Fatty Acids (FFAs)
FFAs blood level at the 3th sample, week 3
|
0.51 mmol/L
Standard Deviation 0.03
|
0.63 mmol/L
Standard Deviation 0.04
|
PRIMARY outcome
Timeframe: baseline, week 2, week 3Outcome measures
| Measure |
Metformin & Acupuncture
n=19 Participants
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
|
Metformin & Placebo
n=20 Participants
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
|
|---|---|---|
|
Triglyceride (TG)
TG blood level at the 2th sample, week 2
|
2.44 mmol/L
Standard Deviation 0.6
|
2.69 mmol/L
Standard Deviation 0.7
|
|
Triglyceride (TG)
TG blood level at the 1th sample, baseline
|
2.59 mmol/L
Standard Deviation 0.6
|
2.69 mmol/L
Standard Deviation 0.7
|
|
Triglyceride (TG)
TG blood level at the 3th sample, week 3
|
2.24 mmol/L
Standard Deviation 0.5
|
2.65 mmol/L
Standard Deviation 0.7
|
PRIMARY outcome
Timeframe: baseline, week 2, week 3Outcome measures
| Measure |
Metformin & Acupuncture
n=19 Participants
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
|
Metformin & Placebo
n=20 Participants
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
|
|---|---|---|
|
Low Density Lipoprotein Cholesterol (LDLc)
LDLc blood level at the 1th sample, baseline
|
4.05 mmol/L
Standard Deviation 0.5
|
4.08 mmol/L
Standard Deviation 0.5
|
|
Low Density Lipoprotein Cholesterol (LDLc)
LDLc blood level at the 2th sample, week 2
|
3.88 mmol/L
Standard Deviation 0.5
|
4.0 mmol/L
Standard Deviation 0.5
|
|
Low Density Lipoprotein Cholesterol (LDLc)
LDLc blood level at the 3th sample, week 3
|
3.68 mmol/L
Standard Deviation 0.5
|
3.95 mmol/L
Standard Deviation 0.5
|
PRIMARY outcome
Timeframe: baseline, week 2, week 3HDLc 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.
Outcome measures
| Measure |
Metformin & Acupuncture
n=19 Participants
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
|
Metformin & Placebo
n=20 Participants
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
|
|---|---|---|
|
High Density Lipoprotein Cholesterol (HDLc)
HDLc blood level at the 1th sample, baseline
|
1.08 mmol/L
Standard Deviation 0.1
|
1.16 mmol/L
Standard Deviation 0.1
|
|
High Density Lipoprotein Cholesterol (HDLc)
HDLc blood level at the 2th sample, week 2
|
1.20 mmol/L
Standard Deviation 0.1
|
1.21 mmol/L
Standard Deviation 0.1
|
|
High Density Lipoprotein Cholesterol (HDLc)
HDLc blood level at the 3th sample, week 3
|
1.29 mmol/L
Standard Deviation 0.1
|
1.25 mmol/L
Standard Deviation 0.1
|
PRIMARY outcome
Timeframe: baseline, week 2, week 3Changes 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.
Outcome measures
| Measure |
Metformin & Acupuncture
n=19 Participants
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
|
Metformin & Placebo
n=20 Participants
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
|
|---|---|---|
|
Ceramides
ceramides blood level at the 1th sample, baseline
|
8.06 g/dl
Standard Deviation 0.2
|
7.92 g/dl
Standard Deviation 0.2
|
|
Ceramides
ceramides blood level at the 2th sample, week 2
|
7.24 g/dl
Standard Deviation 0.3
|
7.45 g/dl
Standard Deviation 0.2
|
|
Ceramides
ceramides blood level at the 3th sample, week 3
|
6.06 g/dl
Standard Deviation 0.3
|
7.18 g/dl
Standard Deviation 0.2
|
PRIMARY outcome
Timeframe: baseline, week 2, week 3changes 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.
Outcome measures
| Measure |
Metformin & Acupuncture
n=19 Participants
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
|
Metformin & Placebo
n=20 Participants
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
|
|---|---|---|
|
Leptin
Leptin blood level at the 1th sample, baseline
|
13.32 ng/ml
Standard Deviation 0.2
|
13.35 ng/ml
Standard Deviation 0.2
|
|
Leptin
Leptin blood level at the 2th sample, week 2
|
11.58 ng/ml
Standard Deviation 0.4
|
12.67 ng/ml
Standard Deviation 0.4
|
|
Leptin
Leptin blood level at the 3th sample, week 3
|
10.84 ng/ml
Standard Deviation 0.4
|
12.60 ng/ml
Standard Deviation 0.4
|
PRIMARY outcome
Timeframe: baseline, week 2, week 3Changes 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.
Outcome measures
| Measure |
Metformin & Acupuncture
n=19 Participants
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
|
Metformin & Placebo
n=20 Participants
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
|
|---|---|---|
|
Adiponectin
Adiponectin blood level at the 2th sample, week 2
|
8.26 µg/ml
Standard Deviation 0.2
|
7.58 µg/ml
Standard Deviation 0.3
|
|
Adiponectin
Adiponectin blood level at the baseline
|
7.47 µg/ml
Standard Deviation 0.3
|
7.48 µg/ml
Standard Deviation 0.2
|
|
Adiponectin
Adiponectin blood level at the 3th sample, week 3
|
8.73 µg/ml
Standard Deviation 0.2
|
7.73 µg/ml
Standard Deviation 0.3
|
PRIMARY outcome
Timeframe: baseline, week 2, week 3changes 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.
Outcome measures
| Measure |
Metformin & Acupuncture
n=19 Participants
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
|
Metformin & Placebo
n=20 Participants
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
|
|---|---|---|
|
Glucagon-like Peptide-1 (GLP-1)
GLP-1 blood level at the 1th sample, baseline
|
3.77 mmol/L
Standard Deviation 0.2
|
3.75 mmol/L
Standard Deviation 0.2
|
|
Glucagon-like Peptide-1 (GLP-1)
GLP-1 blood level at the 2th sample, week 2
|
3.49 mmol/L
Standard Deviation 0.2
|
3.50 mmol/L
Standard Deviation 0.2
|
|
Glucagon-like Peptide-1 (GLP-1)
GLP-1 blood level at the 3th sample, week 3
|
3.21 mmol/L
Standard Deviation 0.1
|
3.43 mmol/L
Standard Deviation 0.2
|
PRIMARY outcome
Timeframe: baseline, week 2, week 3Changes 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.
Outcome measures
| Measure |
Metformin & Acupuncture
n=19 Participants
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
|
Metformin & Placebo
n=20 Participants
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
|
|---|---|---|
|
Resistin
Resistin blood level at the 1th sample, baseline
|
7.43 ng/ml
Standard Deviation 0.2
|
7.36 ng/ml
Standard Deviation 0.2
|
|
Resistin
Resistin blood level at the 2th sample, week 2
|
6.34 ng/ml
Standard Deviation 0.3
|
6.76 ng/ml
Standard Deviation 0.2
|
|
Resistin
Resistin blood level at the 3th sample, week 3
|
5.24 ng/ml
Standard Deviation 0.3
|
6.54 ng/ml
Standard Deviation 0.1
|
PRIMARY outcome
Timeframe: baseline, week 2, week 3changes 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.
Outcome measures
| Measure |
Metformin & Acupuncture
n=19 Participants
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
|
Metformin & Placebo
n=20 Participants
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
|
|---|---|---|
|
Serotonin
Serotonin blood level at the 1th sample, baseline
|
130.4 ng/ml
Standard Deviation 3
|
128 ng/ml
Standard Deviation 2
|
|
Serotonin
Serotonin blood level at the 2th sample, week 2
|
144.9 ng/ml
Standard Deviation 2
|
135.1 ng/ml
Standard Deviation 2
|
|
Serotonin
Serotonin blood level at the 3th sample, week 3
|
170.5 ng/ml
Standard Deviation 3
|
147 ng/ml
Standard Deviation 3
|
SECONDARY outcome
Timeframe: baseline, week 3change of BMI. Body height was measured to an accuracy of +/-0.1cm. BMI was calculated by dividing weight (kg) into height (squared m²).
Outcome measures
| Measure |
Metformin & Acupuncture
n=19 Participants
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
|
Metformin & Placebo
n=20 Participants
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
|
|---|---|---|
|
Body Mass Index (BMI)
BMI blood level at the 3th sample, week 3
|
26.2 Kg/m²
Standard Deviation 2.4
|
27.7 Kg/m²
Standard Deviation 1.6
|
|
Body Mass Index (BMI)
BMI blood level at the 1th sample, baseline
|
27.6 Kg/m²
Standard Deviation 2.5
|
28.2 Kg/m²
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: baseline, week 2, week 3Changes 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.
Outcome measures
| Measure |
Metformin & Acupuncture
n=19 Participants
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
|
Metformin & Placebo
n=20 Participants
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
|
|---|---|---|
|
HOMA-IR
HOMA-IR at the 1th sample, baseline
|
4.25 units on a scale
Standard Deviation 0.2
|
4.36 units on a scale
Standard Deviation 0.6
|
|
HOMA-IR
HOMA-IR at the 2th sample, week 2
|
3.68 units on a scale
Standard Deviation 0.1
|
4.06 units on a scale
Standard Deviation 0.5
|
|
HOMA-IR
HOMA-IR at the 3th sample, week 3
|
2.67 units on a scale
Standard Deviation 0.1
|
4.01 units on a scale
Standard Deviation 0.5
|
Adverse Events
Metformin & Acupuncture
Metformin & Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place