Clinical trial NCT02438540: Comparative the Effect of Metformin and Acupuncture on Weight Loss and Insulin Sensitivity
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 Sensitivity in Diabetic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insulin Sensitivity
Obesity
Keywords: acupuncture
obesity
type 2 diabetic mellitus
insulin sensitivity
metformin
inflammatory factor
adipokines
lipid profile
Lead sponsor: Nanjing University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2015-05-08
Enrollment: 43
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Body Weight
timeFrame: baseline, week 3
measure: Fasting Blood Sugar (FBS)
timeFrame: baseline, week 2, week 3
measure: Fasting Insulin (FINS)
timeFrame: baseline, week 2, week 3
measure: Interleukin-6 (IL-6)
timeFrame: baseline, week 2, week 3
measure: Tumor Necrosis Factor-α (TNF-α)
timeFrame: baseline, week 2, week 3
measure: C-reaction Protein (CRP)
timeFrame: baseline, week 2, week 3
measure: Free Fatty Acids (FFAs)
timeFrame: baseline, week 2, week 3
measure: Triglyceride (TG)
timeFrame: baseline, week 2, week 3
measure: Low Density Lipoprotein Cholesterol (LDLc)
timeFrame: baseline, week 2, week 3
measure: High Density Lipoprotein Cholesterol (HDLc)
timeFrame: baseline, week 2, week 3
measure: Ceramides
timeFrame: baseline, week 2, week 3
measure: Leptin
timeFrame: baseline, week 2, week 3
measure: Adiponectin
timeFrame: baseline, week 2, week 3
measure: Glucagon-like Peptide-1 (GLP-1)
timeFrame: baseline, week 2, week 3
measure: Resistin
timeFrame: baseline, week 2, week 3
measure: Serotonin
timeFrame: baseline, week 2, week 3
Secondary outcomes:
measure: Body Mass Index (BMI)
timeFrame: baseline, week 3
measure: HOMA-IR
timeFrame: baseline, week 2, week 3
Other outcomes:
Locations:
Study officials:
affiliation: Nanjing University of Traditional Chinese Medicine
name: Amir Firouzjaei, Clinical PhD
role: PRINCIPAL_INVESTIGATOR
References: