Acupuncture in the Regulation of Dai Meridian for the Metabolism of Visceral Adipose Tissue in Abdominal Obese Patients

Study Overview
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Brief Summary
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To evaluate the effectiveness of acupuncture therapy combined with healthy education for patients with abdominal obesity.

Detailed Description
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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.

Official Title
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A Randomized Controlled Clinical Trial of Acupuncture on Regulating Dai Meridian for Visceral Fat Metabolism in Abdominal Obesity.

Conditions
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Abdominal Obesity, Metabolic Syndrome

Intervention / Treatment
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* Other: Acupuncture
* Other: Healthy education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Intervention including acupuncture treatment and healthy education. | Other: Acupuncture<br>* Acupuncture needles of 0.3mm in diameter and 100mm in length are inserted into gallbladder-meridian(GB)26 about 25-65mm deep by an angle of 15°, following the path of Dai Meridian (towards medial and downside) . The other acupoints are inserted with needles of 0.25-0.3mm in diameter and 25-40mm in length approximately 10-30mm deep, with an angle of 90°. Electro-acupuncture is applied to both sides of GB26 and stomach-meridian(ST)25: cathode is connected to GB26; anode to ST25. Dense-disperse wave pattern and a wave frequency of 2/100 Hertz is chosen. The intensity of the electro-acupuncture is adjusted on average 4-8 milliampere. The needles are subsequently retained for 20min. The results of the study are based on 8 weeks, each week consisting of 3 sessions.<br>Other: Healthy education<br>* Healthy knowledge lectures and issuing brochures are given. Education of patients for conditioning and changing bad habits, diet, quit smoking, limit alcohol consumption, salt restriction, appropriate increase in physical activity.<br>|
| Other: Control group<br>Healthy education is given as a baseline treatment. | Other: Healthy education<br>* Healthy knowledge lectures and issuing brochures are given. Education of patients for conditioning and changing bad habits, diet, quit smoking, limit alcohol consumption, salt restriction, appropriate increase in physical activity.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from Baseline in abdominal subcutaneous fat thickness at 8 weeks | Including subcutaneous fat thickness 1 and 2 | baseline and 8 weeks | 
| Changes from Baseline in abdominal visceral fat thickness at 8 weeks | Including visceral fat thickness 1 and 2 | baseline and 8 weeks | 
| Change from Baseline in antero-hepatic fat thickness at 8 weeks | Antero-hepatic fat thickness (AHF) was determined by the distance of peritoneum to the hepatic cortex at the subcostal level. | baseline and 8 weeks | 
| Change from Baseline in perirenal fat thickness at 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. | baseline and 8 weeks | 
| Change from Baseline in ultrasound viscerofatty index at 8 weeks | ultrasound viscerofatty index (UVI) = (visceral fat thickness 1 + visceral fat thickness2)/(subcutaneous fat thickness 1 + subcutaneous fat thickness 2) | baseline and 8 weeks | 
| Change from Baseline in fasting serum visfatin at 8 weeks | 5ml venous blood was told after an 8 hours fast. Visfatin was measured by enzyme-linkedimmuno sorbent assay (ELISA). | baseline and 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in body weight | It's made at the situation of fasting, after emptying bowels, with minimal clothing, without headdress and footwear, at the end of expiration. | baseline, 4 weeks and 8 weeks | 
| Change from Baseline in body mass index | Body mass index (BMI) = body weight(kg)/height(m)/height(m) | baseline, 4 weeks and 8 weeks | 
| Change from Baseline in waist circumference | WC was measured at the level between the inferior portion of 12th rib and iliac crest. | baseline, 4 weeks and 8 weeks | 
| Change from Baseline in hip circumference | HC was measured at the level of the most prominent point of the pelvis. | baseline, 4 weeks and 8 weeks | 
| Change from Baseline in waist-to-hip radio | waist-to-hip radio (WHR) = waist circumference(cm)/hip circumference(cm) | baseline, 4 weeks and 8 weeks | 
| Change from Baseline in waist-to-height radio | waist-to-height radio (WHtR) = waist circumference(cm)/height(cm) | baseline, 4 weeks and 8 weeks | 
| Change from Baseline in the percentage of body fat | the percentage of body fat = 1.2×BMI+0.23×age-5.4-10.8×gender（M=1，F=0） | baseline, 4 weeks and 8 weeks | 
| Change from Baseline in fasting blood glucose at 8 weeks | 5ml venous blood was collected after an 8 hours fast. It was tested by our hospital's laboratory. | baseline and 8 weeks | 
| Change from Baseline in fasting insulin at 8 weeks | 5ml venous blood was collected after an 8 hours fast. It was tested by our hospital's laboratory. | baseline and 8 weeks | 
| Change from Baseline in glycosylated hemoglobin at 8 weeks | 5ml venous blood was collected after an 8 hours fast. It was tested by our hospital's laboratory. | baseline and 8 weeks | 
| Change from Baseline in fasting total cholesterol at 8 weeks | 5ml venous blood was collected after an 8 hours fast. It was tested by our hospital's laboratory. | baseline and 8 weeks | 
| Change from Baseline in fasting triglyceride at 8 weeks | 5ml venous blood was collected after an 8 hours fast. It was tested by our hospital's laboratory. | baseline and 8 weeks | 
| Change from Baseline in fasting high density lipoprotein cholesterol at 8 weeks | 5ml venous blood was collected after an 8 hours fast. It was tested by our hospital's laboratory. | baseline and 8 weeks | 
| Change from Baseline in fasting low density lipoprotein cholesterol at 8 weeks | 5ml venous blood was collected after an 8 hours fast. It was tested by our hospital's laboratory. | baseline and 8 weeks | 
| Change from Baseline in fasting uric acid at 8 weeks | 5ml venous blood was collected after an 8 hours fast. It was tested by our hospital's laboratory. | baseline and 8 weeks | 
| Change from Baseline in blood pressure 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 obesity related lifestyle survey at 8 weeks |  | baseline and 8 weeks |