Acupuncture for Obesity on Serum Metabolic Parameters
Effects of Acupuncture on Serum Metabolic Parameters in Pre-menopausal Obese Women: A Randomized Controlled Trial
研究概览
详细说明
It is consisted with two sub research.
First, clinical research to assess the effect of acupuncture for obesity on serum metabolic parameters will be processed with randomized, patient-assessor blinding, and sham-acupuncture controlled study design. 120 subjects would be collected and divided into two groups(experimental and placebo, 60 subjects each). Experimental group will undergo with real acupuncture treatment(manual acupuncture + electroacupuncture) twice a week, for 6 weeks. The effect on serum metabolic parameters will be assessed at 0 and 6 weeks.
Second is qualitative research to make a basis through the evaluation of economic efficacy and patients' satisfaction with acupuncture treatment for obesity.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
-
Seoul、大韩民国、134-727
- Kyung Hee University Korean Medicine Hospital at Gangdong
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- volunteers through announcements and advertisements
- premenopausal adult women (19 years of age or more)
- clinical diagnosis of obesity (Body mass index: 25 kg/m2 or more)
Exclusion Criteria:
- previously or currently having endocrine disease such as hypothyroidism or Cushing's syndrome, heart disease, lung disease, diabetes, malignant tumor, cholelithiasis, severe kidney impairment, severe liver impairment, anorexia nervosa or hyperorexia
- experience of taking medicines which might affect body weight and the concentration of serum metabolic parameters such as anorectic, laxative, oral steroid, thyroid hormone, amphetamine, cyproheptadine, phenothiazine, or medicines affecting absorption, metabolism, and excretion in the past 3 months
- experience of taking beta-blocker or diuretic for the treatment of hypertension in the past 3 months
- surgical treatment for the treatment of obesity
- currently or might be pregnant or breast-feeding
- experience of taking other experimental medicines in the past month
- weight loss of 10% or more of previous body weight in the past 6 months
- who stopped smoking in the past 3 months or who have irregular smoking habit
- pacemaker
- currently receiving any treatment for obesity
- other inadequate subjects assessed by the study investigators
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:Real acupuncture
manual acupuncture + electroacupuncture, twice a week, for 6 weeks
|
manual acupuncture (bilateral LI4, LI11, SP6, ST25, ST28, ST36) + electroacupuncture (middle CV6, CV12), twice a week, for 6 weeks common approaches for the treatment of obesity used by doctors of Korean medicine in Korea today |
假比较器:Sham acupuncture
sham acupuncture + placebo acupuncture without electrical stimulation, twice a week, for 6 weeks
|
sham acupuncture (bilateral LI4, LI11, SP6, ST25, ST28, ST36) + placebo acupuncture without electrical stimulation (middle CV6, CV12), twice a week, for 6 weeks sham acupuncture (0.25mm diameter x 40mm length, stainless steel, Acuprime, UK) as control for manual acupuncture (0.25mm diameter x 40mm length, stainless steel, Dongbangacupuncture Inc., Korea) placebo acupuncture without electrical stimulation as control for electroacupuncture (0.25mm diameter x 90mm length, stainless steel, Dongbangacupuncture Inc., Korea) |
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
change in serum metabolic profile
大体时间:before treatment at week1 (baseline) and after treatment at week6 (endpoint)
|
before treatment at week1 (baseline) and after treatment at week6 (endpoint)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
change in body weight
大体时间:baseline, 1, 2, 3, 4, 5, and 6 weeks
|
using bioelectrical impedance analysis (BIA)
|
baseline, 1, 2, 3, 4, 5, and 6 weeks
|
change in body fat mass
大体时间:baseline, 1, 2, 3, 4, 5, and 6 weeks
|
using bioelectrical impedance analysis (BIA)
|
baseline, 1, 2, 3, 4, 5, and 6 weeks
|
change in muscle mass
大体时间:baseline, 1, 2, 3, 4, 5, and 6 weeks
|
using bioelectrical impedance analysis (BIA)
|
baseline, 1, 2, 3, 4, 5, and 6 weeks
|
change in waist circumference
大体时间:baseline, 1, 2, 3, 4, 5, and 6 weeks
|
baseline, 1, 2, 3, 4, 5, and 6 weeks
|
|
change in hip circumference
大体时间:baseline, 1, 2, 3, 4, 5, and 6 weeks
|
baseline, 1, 2, 3, 4, 5, and 6 weeks
|
|
change in Beck Depression Index (BDI)
大体时间:baseline and 6 weeks
|
baseline and 6 weeks
|
|
change in Social Readjustment Rating Scale (SRRS)
大体时间:baseline and 6 weeks
|
baseline and 6 weeks
|
|
change in Stress Response Inventory (SRI)
大体时间:baseline and 6 weeks
|
baseline and 6 weeks
|
|
change in International Physical Activity Questionnaire (IPAQ)
大体时间:baseline and 6 weeks
|
baseline and 6 weeks
|
|
change in Fatigue Severity Scale (FSS)
大体时间:baseline, 1, 2, 3, 4, 5, and 6 weeks
|
baseline, 1, 2, 3, 4, 5, and 6 weeks
|
|
heart rate variability (HRV)
大体时间:just before treatment at visit1(baseline), 10 minutes after treatment at visit1, just before treatment at visit12 (6 weeks), 10 minutes after treatment at visit12(end point)
|
just before treatment at visit1(baseline), 10 minutes after treatment at visit1, just before treatment at visit12 (6 weeks), 10 minutes after treatment at visit12(end point)
|
|
number of participants with adverse events
大体时间:up to the end of study
|
|
up to the end of study
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
---|---|---|
change in Measure Yourself Medical Outcome Profile (MYMOP)
大体时间:baseline, 1, 2, 3, 4, 5, and 6 weeks
|
outcome measure for the evaluation of patients' satisfaction and economic efficacy in secondary sub-study
|
baseline, 1, 2, 3, 4, 5, and 6 weeks
|
change in EuroQol-5 Dimension (EQ-5D)
大体时间:baseline and 6 weeks
|
outcome measure for the evaluation of patients' satisfaction and economic efficacy in secondary sub-study
|
baseline and 6 weeks
|
合作者和调查者
调查人员
- 首席研究员:Mi-Yeon Song, Ph.D.、Department of Rehabilitation Medicine of Korean Medicine, Kyung Hee University Gangdong Hospital
出版物和有用的链接
一般刊物
- Kim KW, Shin WC, Choi MS, Cho JH, Park HJ, Yoo HH, Song MY. Effects of acupuncture on anthropometric and serum metabolic parameters in premenopausal overweight and obese women: a randomized, patient- and assessor-blind, sham-controlled clinical trial. Acupunct Med. 2021 Feb;39(1):30-40. doi: 10.1177/0964528420912259. Epub 2020 Apr 17.
- Kim KW, Yoo HH, Cho JH, Yang YC, Kim JI, Kim SY, Park JY, Park HJ, Song MY. Effects of acupuncture on serum metabolic parameters in premenopausal obese women: study protocol for a randomized controlled trial. Trials. 2015 Aug 4;16:327. doi: 10.1186/s13063-015-0867-y.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
Real acupuncture的临床试验
-
The Hong Kong Polytechnic UniversityThe University of Hong Kong; University of Magdeburg; University of Waterloo招聘中
-
University of California, San Francisco招聘中