A Randomized Controlled Clinical Trial of Acupuncture on Regulating Dai Meridian for Visceral Fat Metabolism in Abdominal Obesity.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change from Baseline in fasting serum visfatin at 8 weeks
研究概览
简要总结
To evaluate the effectiveness of acupuncture therapy combined with healthy education for patients with abdominal obesity.
详细描述
This subject is a prospective, single-blind, parallel-group, randomized controlled clinical trial.120 patients with abdominal obesity are allocated into two groups with a ratio of 2:1.Randomized series was generated by computer. The allocation was concealed. Patients in the intervention group are received acupuncture therapy and healthy education. Patients in the control group are only given healthy education. The treatment in both intervention group and control group lasts for 8 weeks. Comparison of two groups of patients with abdominal fat thickness, fasting serum visfatin concentration, simple anthropometric parameters (including body weight, body mass index, waist circumference, hip circumference, waist-to-hip radio, waist-to-height radio, the percentage of body fat), fasting blood glucose, fasting insulin, glycosylated hemoglobin, fasting blood lipid (total cholesterol, triglyceride, high density lipoprotein, low density lipoprotein), uric acid, blood pressure, insulin resistance level, and obesity related lifestyle survey.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Met the diagnostic criteria of abdominal obesity (waist circumference of male ≥ 90cm, waist circumference of female ≥ 80cm);
- •Ultrasound viscerofatty index ≥ 3;
- •Age between 18-70 years old;
- •Signed informed consent voluntarily.
排除标准
- •Secondary obesity caused by endocrine, hereditary, nervous system,or drugs;
- •Within 3 months adjusted drug therapy for diabetes or hypertension or hyperlipidemia;
- •undergoing other therapies for reducing body mass and waist circumference, such as surgery, medication, etc;
- •participating or have participated in other studies;
- •pregnant or breast-feeding women;
- •critically ill, having hepatic-renal dysfunction or mental illness;
- •severe impairment in sight and hearing.
研究组 & 干预措施
Intervention group
Intervention including acupuncture treatment and healthy education.
干预措施: Acupuncture (Other)
Intervention group
Intervention including acupuncture treatment and healthy education.
干预措施: Healthy education (Other)
Control group
Healthy education is given as a baseline treatment.
干预措施: Healthy education (Other)
结局指标
主要结局
Change from Baseline in fasting serum visfatin at 8 weeks
时间窗: baseline and 8 weeks
5ml venous blood was told after an 8 hours fast. Visfatin was measured by enzyme-linkedimmuno sorbent assay (ELISA).
Changes from Baseline in abdominal subcutaneous fat thickness at 8 weeks
时间窗: baseline and 8 weeks
Including subcutaneous fat thickness 1 and 2
Change from Baseline in antero-hepatic fat thickness at 8 weeks
时间窗: baseline and 8 weeks
Antero-hepatic fat thickness (AHF) was determined by the distance of peritoneum to the hepatic cortex at the subcostal level.
Changes from Baseline in abdominal visceral fat thickness at 8 weeks
时间窗: baseline and 8 weeks
Including visceral fat thickness 1 and 2
Change from Baseline in perirenal fat thickness at 8 weeks
时间窗: baseline and 8 weeks
Perirenal fat thickness (PRF) was determined by the thickest one of the perirenal fat capsule of the right kidney short axis, when the right renal short axis and the maximum width of the renal sinus were clearly displayed.
Change from Baseline in ultrasound viscerofatty index at 8 weeks
时间窗: baseline and 8 weeks
ultrasound viscerofatty index (UVI) = (visceral fat thickness 1 + visceral fat thickness2)/(subcutaneous fat thickness 1 + subcutaneous fat thickness 2)
次要结局
- Change from Baseline in waist circumference(baseline, 4 weeks and 8 weeks)
- Change from Baseline in body weight(baseline, 4 weeks and 8 weeks)
- Change from Baseline in fasting insulin at 8 weeks(baseline and 8 weeks)
- Change from Baseline in insulin resistance level at 8 weeks(baseline and 8 weeks)
- Change from Baseline in body mass index(baseline, 4 weeks and 8 weeks)
- Change from Baseline in hip circumference(baseline, 4 weeks and 8 weeks)
- Change from Baseline in waist-to-hip radio(baseline, 4 weeks and 8 weeks)
- Change from Baseline in fasting total cholesterol at 8 weeks(baseline and 8 weeks)
- Change from Baseline in fasting triglyceride at 8 weeks(baseline and 8 weeks)
- Change from Baseline in fasting high density lipoprotein cholesterol at 8 weeks(baseline and 8 weeks)
- Change from Baseline in obesity related lifestyle survey at 8 weeks(baseline and 8 weeks)
- Change from Baseline in waist-to-height radio(baseline, 4 weeks and 8 weeks)
- Change from Baseline in the percentage of body fat(baseline, 4 weeks and 8 weeks)
- Change from Baseline in fasting blood glucose at 8 weeks(baseline and 8 weeks)
- Change from Baseline in glycosylated hemoglobin at 8 weeks(baseline and 8 weeks)
- Change from Baseline in fasting low density lipoprotein cholesterol at 8 weeks(baseline and 8 weeks)
- Change from Baseline in fasting uric acid at 8 weeks(baseline and 8 weeks)
- Change from Baseline in blood pressure at 8 weeks(baseline and 8 weeks)
研究者
Hui Hu
Principal Investigator
Dongfang Hospital Beijing University of Chinese Medicine