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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02438540
• Other study ID #: NanjingUTCM
• Status: Completed
• Phase: N/A
• First received: April 21, 2015
• Last updated: May 5, 2015
• Start date: May 2014
• Est. completion date: April 2015

Study information

• Verified date: May 2015
• Source: Nanjing University of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: April 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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 (with different therapeutic dosage)

• 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

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

Intervention

Drug:
• metformin

Other:
• acupuncture
Electro body acupuncture and auricular acupuncture
• Placebo (for acupuncture including electro body acupuncture and auricular acupuncture)
for those points that were located in the abdomen, needles were inserted 0.3cm 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 0.5cm laterally from the real location and needling was superficial as well. In control group electric lines were connected with some of the needles same way they were connected in 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amir Firouzjaei

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The effect of Metformin and acupuncture combined therapy on weight loss ( Change from baseline in weight), in comparison with Metformin monotherapy in T2DM patients.	Change from baseline in body weight and BMI at 3 weeks	3 weeks	No
Primary	The effect of Metformin and acupuncture combined therapy on IR (change from baseline in IR, as measured by HOMA-IR index), in comparison with Metformin monotherapy in T2DM patients.	change from baseline in IR, as measured by HOMA-IR index at 3 weeks	3 weks	No
Secondary	If acupuncture can be an insulin-sensitizers (Change from baseline in HOMA-IR index),	change from baseline in IR, as measured by HOMA-IR, including FBS and FINS) at 3 weeks	3 weeks	No
Secondary	what is the therapeutic mechanism of acupuncture in weight loss and IR in T2DM patients	Change from baseline in multiple measures including: IL-6, TNFa, CRP, leptin, adiponectin, resistin, Serotonin GLP-1, FFAs, LDLc, HDLc, TG and ceramides indexes.; This is a composite outcome measure	3 weeks	No