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Trials
Published in: Trials 1/2015

Open Access 01-12-2015 | Study protocol

Effects of acupuncture on serum metabolic parameters in premenopausal obese women: study protocol for a randomized controlled trial

Authors: Koh-Woon Kim, Hye Hyun Yoo, Jae-Heung Cho, Yo-Chan Yang, Je-In Kim, Song-Yi Kim, Ji-Yeun Park, Hi-Joon Park, Mi-Yeon Song

Published in: Trials | Issue 1/2015

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Abstract

Background

Complex metabolic changes cause obesity, making weight loss difficult. For this reason, understanding metabolism is important, and considering the shortcomings of conventional treatment options for obesity, acupuncture is a possible option. However, evidence supporting its efficacy on metabolic parameters in obese patients is lacking. The aim of this study is to investigate the effects of acupuncture on serum metabolic parameters in premenopausal obese women.

Methods/design

This ongoing study is a randomized, patient-assessor blind, two-arm parallel non-penetrating sham-controlled clinical trial. Eligible participants, premenopausal adult women (19 years of age or older) with a clinical diagnosis of obesity (body mass index of 25 kg/m2 or more) blinded to the treatment received, will be randomly allocated blindly into the real acupuncture treatment group (manual acupuncture plus electroacupuncture, n = 60) or the sham acupuncture control group (sham acupuncture plus placebo acupuncture without electrical stimulation, n = 60) and receive treatment two times a week for a total of 12 sessions over 6 weeks. The primary outcome measure is the serum cholesterol and triglyceride (TG) levels at baseline and endpoint. The secondary outcomes are body weight, body fat mass, muscle mass, waist and hip circumference, other serum metabolic profiles, International Physical Activity Questionnaire (IPAQ), Social Readjustment Rating Scale (SRRS), Stress Response Inventory (SRI), Fatigue Severity Scale (FSS), the Korean version of the Beck Depression Inventory (BDI), and urine metabolites. Adverse events will be assessed at every visit.

Discussion

The results of this trial (which will be available in 2015) will provide important clinical evidence for the effect of acupuncture on serum metabolites and demonstrate how acupuncture can be helpful for the treatment of obesity.

Trial registration

Trial registration registered via US National Institutes of Health Clinical Trials registry (ClinicalTrials.gov) on 11 November 2014, identifier: NCT02066090.
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Metadata
Title
Effects of acupuncture on serum metabolic parameters in premenopausal obese women: study protocol for a randomized controlled trial
Authors
Koh-Woon Kim
Hye Hyun Yoo
Jae-Heung Cho
Yo-Chan Yang
Je-In Kim
Song-Yi Kim
Ji-Yeun Park
Hi-Joon Park
Mi-Yeon Song
Publication date
01-12-2015
Publisher
BioMed Central
Published in
Trials / Issue 1/2015
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-015-0867-y

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