N/A Completed N=39 Randomized Double-blind Treatment

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

Insulin Sensitivity · Obesity

Source: ClinicalTrials.gov NCT02438540 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2016

Primary outcomePrimary: Body Weight — -4.1; -1.5 kg — p=<0.001

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Body Weight	-4.1; -1.5	<0.001 sig
PRIMARY Fasting Blood Sugar (FBS)	6.65; 6.67; 6.44; 6.55; 6.12; 6.54	<0.001 sig
PRIMARY Fasting Insulin (FINS)	14.47; 14.45; 12.92; 13.75; 9.91; 13.6	<0.001 sig
PRIMARY Interleukin-6 (IL-6)	1.44; 1.43; 1.30; 1.41; 1.09; 1.37	<0.001 sig
PRIMARY Tumor Necrosis Factor-α (TNF-α)	1.44; 1.44; 1.42; 1.43; 1.41; 1.43	0.04 sig
PRIMARY C-reaction Protein (CRP)	0.60; 0.59; 0.59; 0.58; 0.57; 0.57	0.082
PRIMARY Free Fatty Acids (FFAs)	0.72; 0.72; 0.61; 0.70; 0.51; 0.63	<0.001 sig
PRIMARY Triglyceride (TG)	2.59; 2.69; 2.44; 2.69; 2.24; 2.65	<0.001 sig
PRIMARY Low Density Lipoprotein Cholesterol (LDLc)	4.05; 4.08; 3.88; 4.0; 3.68; 3.95	<0.001 sig
PRIMARY High Density Lipoprotein Cholesterol (HDLc)	1.08; 1.16; 1.20; 1.21; 1.29; 1.25	<0.001 sig
PRIMARY Ceramides	8.06; 7.92; 7.24; 7.45; 6.06; 7.18	<0.001 sig
PRIMARY Leptin	13.32; 13.35; 11.58; 12.67; 10.84; 12.60	<0.001 sig
PRIMARY Adiponectin	7.47; 7.48; 8.26; 7.58; 8.73; 7.73	<0.001 sig
PRIMARY Glucagon-like Peptide-1 (GLP-1)	3.77; 3.75; 3.49; 3.50; 3.21; 3.43	<0.001 sig
PRIMARY Resistin	7.43; 7.36; 6.34; 6.76; 5.24; 6.54	<0.001 sig
PRIMARY Serotonin	130.4; 128; 144.9; 135.1; 170.5; 147	<0.001 sig
SECONDARY Body Mass Index (BMI)	27.6; 28.2; 26.2; 27.7	<0.001 sig
SECONDARY HOMA-IR	4.25; 4.36; 3.68; 4.06; 2.67; 4.01	<0.001 sig

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02438540). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.