Comparative the Effect of Metformin and Acupuncture on Weight Loss and Insulin Sensitivity
Placebo-controlled, Randomized, Double Blind Trial, What is the Therapeutic Effect of Metformin and Acupuncture Combined Therapy in Comparison With Metformin Monotherapy on Weight Loss and Insulin Sensitivity in Diabetic Patients
Tutkimuksen yleiskatsaus
Tila
Tila
Ehdot
Ehdot
Interventio / Hoito
Interventio / Hoito
Yksityiskohtainen kuvaus
Opintotyyppi
Opintotyyppi
Ilmoittautuminen (Todellinen)
Ilmoittautuminen
Vaihe
Vaihe
- Ei sovellettavissa
Osallistumiskriteerit
Kelpoisuusvaatimukset
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
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
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Kaksinkertainen
Aseiden lukumäärä
Aseet ja interventiot
Osallistujaryhmä / ArmOsallistujaryhmä / Arm |
Interventio / HoitoInterventio / Hoito |
|---|---|
|
Kokeellinen: 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 tablet 500 mg
Electro body acupuncture and auricular acupuncture
|
|
Placebo Comparator: 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 tablet 500 mg
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Body Weight
Aikaikkuna: 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.
|
baseline, week 3
|
|
Fasting Blood Sugar (FBS)
Aikaikkuna: 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.
|
baseline, week 2, week 3
|
|
Fasting Insulin (FINS)
Aikaikkuna: 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.
|
baseline, week 2, week 3
|
|
Interleukin-6 (IL-6)
Aikaikkuna: 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.
|
baseline, week 2, week 3
|
|
Tumor Necrosis Factor-α (TNF-α)
Aikaikkuna: 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.
|
baseline, week 2, week 3
|
|
C-reaction Protein (CRP)
Aikaikkuna: 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.
|
baseline, week 2, week 3
|
|
Free Fatty Acids (FFAs)
Aikaikkuna: 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.
|
baseline, week 2, week 3
|
|
Triglyceride (TG)
Aikaikkuna: baseline, week 2, week 3
|
baseline, week 2, week 3
|
|
|
Low Density Lipoprotein Cholesterol (LDLc)
Aikaikkuna: baseline, week 2, week 3
|
baseline, week 2, week 3
|
|
|
High Density Lipoprotein Cholesterol (HDLc)
Aikaikkuna: 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.
|
baseline, week 2, week 3
|
|
Ceramides
Aikaikkuna: 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.
|
baseline, week 2, week 3
|
|
Leptin
Aikaikkuna: 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.
|
baseline, week 2, week 3
|
|
Adiponectin
Aikaikkuna: 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.
|
baseline, week 2, week 3
|
|
Glucagon-like Peptide-1 (GLP-1)
Aikaikkuna: 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.
|
baseline, week 2, week 3
|
|
Resistin
Aikaikkuna: 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.
|
baseline, week 2, week 3
|
|
Serotonin
Aikaikkuna: 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.
|
baseline, week 2, week 3
|
Toissijaiset tulostoimenpiteet
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Body Mass Index (BMI)
Aikaikkuna: 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).
|
baseline, week 3
|
|
HOMA-IR
Aikaikkuna: 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.
|
baseline, week 2, week 3
|
Yhteistyökumppanit ja tutkijat
Sponsori
Sponsori
Tutkijat
Tutkijat
- Päätutkija: Amir Firouzjaei, Clinical PhD, Nanjing University of Traditional Chinese Medicine
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Opiskelun aloitus
Ensisijainen valmistuminen (Todellinen)
Ensisijainen valmistuminen
Opintojen valmistuminen (Todellinen)
Opintojen valmistuminen
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Arvio)
Ensimmäinen Lähetetty
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Arvio)
Viimeisin päivitys julkaistu
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
Muut tutkimustunnusnumerot
- NanjingUTCM
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
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