Effects of Acupuncture on Serum Metabolic Parameters in Pre-menopausal Obese Women: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- change in serum metabolic profile
研究概览
简要总结
This research is planned to build a basis about the effect of acupuncture on serum metabolic parameters in pre-menopausal obese women with economic evaluation.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Real acupuncture
manual acupuncture + electroacupuncture, twice a week, for 6 weeks
干预措施: Real acupuncture (Device)
Sham acupuncture
sham acupuncture + placebo acupuncture without electrical stimulation, twice a week, for 6 weeks
干预措施: Sham acupuncture (Device)
结局指标
主要结局
change in serum metabolic profile
时间窗: before treatment at week1 (baseline) and after treatment at week6 (endpoint)
次要结局
- change in hip circumference(baseline, 1, 2, 3, 4, 5, and 6 weeks)
- change in Beck Depression Index (BDI)(baseline and 6 weeks)
- change in International Physical Activity Questionnaire (IPAQ)(baseline and 6 weeks)
- change in muscle mass(baseline, 1, 2, 3, 4, 5, and 6 weeks)
- change in waist circumference(baseline, 1, 2, 3, 4, 5, and 6 weeks)
- change in Social Readjustment Rating Scale (SRRS)(baseline and 6 weeks)
- change in body weight(baseline, 1, 2, 3, 4, 5, and 6 weeks)
- change in Stress Response Inventory (SRI)(baseline and 6 weeks)
- heart rate variability (HRV)(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))
- change in body fat mass(baseline, 1, 2, 3, 4, 5, and 6 weeks)
- change in Fatigue Severity Scale (FSS)(baseline, 1, 2, 3, 4, 5, and 6 weeks)
- number of participants with adverse events(up to the end of study)
研究者
Mi-Yeon Song
Professor, K.M.D., Ph.D.
Kyung Hee University Hospital at Gangdong