Comparative the Effect of Metformin and Acupuncture on Weight Loss and Insulin Sensitivity

NCT ID: NCT02438540

Last Updated: 2016-12-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2015-04-30

Brief 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

Conditions

Insulin Sensitivity; Obesity

Keywords

acupuncture; obesity; type 2 diabetic mellitus; insulin sensitivity; metformin; inflammatory factor; adipokines; lipid profile

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

metformin

Intervention Type: DRUG

metformin tablet 500 mg

acupuncture

Intervention Type: OTHER

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 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.

Group Type: PLACEBO_COMPARATOR

metformin

Intervention Type: DRUG

metformin tablet 500 mg

Interventions

metformin

metformin tablet 500 mg

Intervention Type: DRUG

acupuncture

Electro body acupuncture and auricular acupuncture

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amir Firouzjaei

OTHER

Sponsor Role: lead

Responsible Party

Amir Firouzjaei

Clinical PhD in Chinese medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Amir Firouzjaei, Clinical PhD

Role: PRINCIPAL_INVESTIGATOR

Nanjing University of Traditional Chinese Medicine

Other Identifiers

NanjingUTCM

Identifier Type: -

Identifier Source: org_study_id