Comparative Evaluation of the Therapeutic Effect of Metformin Monotherapy With Metformin and Acupuncture Combined Therapy on Weight Loss and Insulin Resistance in Diabetic Patients

Obesity Clinical Trial

Official title: 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 Resistance in Diabetic Patients

Status Completed

Clinical Trial Summary

The investigators designed this randomized double blind (patients/ assessor) clinical trial to know what is the therapeutic effect of Metformin and acupuncture combined therapy in comparison with Metformin monotherapy on weight loss and insulin resistance (IR) among overweight/obese type 2 diabetes mellitus (T2DM) patients. If acupuncture can be an insulin-sensitizer and what is its therapeutic mechanism.

Clinical Trial Description

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. 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. There were no any statistical differences between two groups in age and duration of therapy (P>0.05). Therefore, the two groups are comparable. 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 ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Insulin Resistance
• Obesity

• NCT number: NCT02438540
• Study type: Interventional
• Source: Nanjing University of Traditional Chinese Medicine
• Status: Completed
• Phase: N/A
• Start date: May 2014
• Completion date: April 2015