Comparative the Effect of Metformin and Acupuncture on Weight Loss and Insulin Sensitivity
Condition: Insulin Sensitivity; Obesity
MeSH terms: Insulin Resistance; Hypersensitivity; Weight Loss
Study type: Interventional

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
    

Intervention name(s): metformin; acupuncture
Intervention type(s): Drug; Other
Intervention description(s): metformin tablet 500 mg; Electro body acupuncture and auricular acupuncture
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: acupuncture; obesity; type 2 diabetic mellitus; insulin sensitivity; metformin; inflammatory factor; adipokines; lipid profile