The Efficacy and Safety of Electro-acupuncture for Abdominal Obesity: Original Study for a Multicenter, Randomized, Sham-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Change from baseline waistline at 8 weeks.
研究概览
简要总结
Electro-acupuncture provides stimulation to acupoints, and has been widely used to treat abdominal obesity in China despite of lack of high-level evidence for treatment efficacy. The study will investigate whether the electroacupuncture can alleviate clinical symptoms and the mechanism of action in patients with abdominal obesity.
详细描述
The study will be a randomized controlled trial from May 2021 to December 2022, including 68 participants with abdominal obesity. The participants will be randomly divided into 2 groups in a 1:1 allocation ratio.The intervention group will receive electroacupuncture; the control group will receive sham acupuncture. Each treatment will last 12 weeks, including 8 weeks of intervention period and 24 weeks of follow-up. The primary outcome is the waist circumference (WC), the secondary outcomes include weight, body mass index (BMI), hipline, waist-hip-ratio (WHR), Insulin resistance index (IRI), blood fat, metabolomics will be used analysis the mechanism. The adverse events will be recorded during the intervention and follow-up period.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients recruited for this study should meet the following inclusion criteria:
- •1.Satisfying the criteria for the diagnosis of abdominal obesity; 2.18 years old≤age≤55 years old; 3.Being able to fully understand and voluntarily sign informed consent.
排除标准
- •Patients with any of the following criteria will be excluded from the study:
- •Presence of endocrine disorders such as: polycystic ovary syndrome; Cushing's syndrome; uncorrected thyroid disease.
- •Presence of diabetes mellitus, or hypertension, or abnormal liver and kidney functions, or mental diseases.
- •Pregnant or lactating state, women who plan to become pregnant within 12 weeks.
- •History of bulimia, anorexia, or any other eating disorders.
- •Use of medications in the past 3 months, such as diet drugs, corticosteroids, antidepressants, which may affect weight or appetite.
- •History of surgical weight loss, postoperative adhesions.
- •History of participating in a clinical study of weight loss or any other therapies to lose weight in the past 3 months.
- •Unable to cooperate with the research caused by other diseases or reasons.
- •Received acupuncture within 6 months before enrollment
结局指标
主要结局
Change from baseline waistline at 8 weeks.
时间窗: week 0,week 4,week 8,week 20,week 32
Waistline will be measured around the abdomen at the level of the umbilicus (belly button).
次要结局
- Change from baseline body weight at 8 weeks.(week 0,week 4,week 8,week 20,week 32)
- Change from baseline body mass index at 8 weeks.(week 0,week 4,week 8,week 20,week 32)
- Change from baseline hip circumference at 8 weeks.(week 0,week 4,week 8,week 20,week 32)
- Change from baseline waist-to-hip ratio at 8 weeks.(week 0,week 4,week 8,week 20,week 32)
- Changes from baseline insulin resistance index at 8 weeks.(week 0, week 8)
- Changes from baseline blood fat at 8 weeks.(week 0, week 8)
- Changes from baseline the Kessler 10 scale at 8weeks.(week 0,week 8,week 32)
- Changes from baseline blood pressure at 8 weeks(week 0,week 4,week 8,week 32)
- Changes from baseline the IWQOL - Lite scale score at 8 weeks(week 0,week 8,week 32)
- Change from baseline the body fat percentage at 8 weeks.(week 0,week 8,week 32)
研究者
Wang Jian
Hubei Provincial Hospital of Traditional Chinese Medicine
Hubei Hospital of Traditional Chinese Medicine