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

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

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

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome; Abdominal Obesity
• Intervention / Treatment: Other: Acupuncture; Other: Healthy education

Detailed Description

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
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100078
      • Department of Acupuncture and Moxibustion, Dongfang Hospital, Beijing University of Chinese Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Intervention including acupuncture treatment and healthy education.	Other: Acupuncture; 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.; Other: Healthy education; 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.
Other: Control group; Healthy education is given as a baseline treatment.	Other: Healthy education; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Dongfang Hospital Beijing University of Chinese Medicine
• Collaborators: Beijing Municipal Science & Technology Commission; Beijing University of Chinese Medicine
• Investigators: Study Chair: Hui Hu, doctor, Department of Acupuncture and Moxibustion, Dongfang Hospital, Beijing University of Chinese Medicine

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): September 1, 2017

Study Registration Dates

• First Submitted: April 13, 2015
• First Submitted That Met QC Criteria: April 27, 2015
• First Posted (Estimate): April 28, 2015

Study Record Updates

• Last Update Posted (Actual): August 17, 2018
• Last Update Submitted That Met QC Criteria: August 16, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Insulin Resistance; Hyperinsulinism; Obesity; Metabolic Syndrome; Obesity, Abdominal
• Other Study ID Numbers: Z141107002514079