To evaluate the effectiveness of acupuncture therapy combined with healthy education for patients with abdominal obesity.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
120
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.
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.
Department of Acupuncture and Moxibustion, Dongfang Hospital, Beijing University of Chinese Medicine
Beijing, Beijing Municipality, China
Changes from Baseline in abdominal subcutaneous fat thickness at 8 weeks
Including subcutaneous fat thickness 1 and 2
Time frame: baseline and 8 weeks
Changes from Baseline in abdominal visceral fat thickness at 8 weeks
Including visceral fat thickness 1 and 2
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 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).
Time frame: baseline and 8 weeks
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.
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Time frame: baseline, 4 weeks and 8 weeks
Change from Baseline in body mass index
Body mass index (BMI) = body weight(kg)/height(m)/height(m)
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: baseline, 4 weeks and 8 weeks
Change from Baseline in waist-to-height radio
waist-to-height radio (WHtR) = waist circumference(cm)/height(cm)
Time frame: 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）
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: baseline and 8 weeks
Change from Baseline in blood pressure at 8 weeks
Time frame: baseline and 8 weeks
Change from Baseline in insulin resistance level at 8 weeks
Time frame: baseline and 8 weeks
Change from Baseline in obesity related lifestyle survey at 8 weeks
Time frame: baseline and 8 weeks