Acupuncture in the Regulation of Dai Meridian for the Metabolism of Visceral Adipose Tissue in Abdominal Obese Patients
Primary Purpose
Abdominal Obesity, Metabolic Syndrome
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Acupuncture
Healthy education
Sponsored by
About this trial
This is an interventional treatment trial for Abdominal Obesity
Eligibility Criteria
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.
Sites / Locations
- Department of Acupuncture and Moxibustion, Dongfang Hospital, Beijing University of Chinese Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Intervention group
Control group
Arm Description
Intervention including acupuncture treatment and healthy education.
Healthy education is given as a baseline treatment.
Outcomes
Primary Outcome Measures
Changes from Baseline in abdominal subcutaneous fat thickness at 8 weeks
Including subcutaneous fat thickness 1 and 2
Changes from Baseline in abdominal visceral fat thickness at 8 weeks
Including visceral fat thickness 1 and 2
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.
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.
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)
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).
Secondary Outcome Measures
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.
Change from Baseline in body mass index
Body mass index (BMI) = body weight(kg)/height(m)/height(m)
Change from Baseline in waist circumference
WC was measured at the level between the inferior portion of 12th rib and iliac crest.
Change from Baseline in hip circumference
HC was measured at the level of the most prominent point of the pelvis.
Change from Baseline in waist-to-hip radio
waist-to-hip radio (WHR) = waist circumference(cm)/hip circumference(cm)
Change from Baseline in waist-to-height radio
waist-to-height radio (WHtR) = waist circumference(cm)/height(cm)
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)
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.
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.
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.
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.
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.
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.
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.
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.
Change from Baseline in blood pressure at 8 weeks
Change from Baseline in insulin resistance level at 8 weeks
Change from Baseline in obesity related lifestyle survey at 8 weeks
Full Information
NCT ID
NCT02427347
First Posted
April 13, 2015
Last Updated
August 16, 2018
Sponsor
Dongfang Hospital Beijing University of Chinese Medicine
Collaborators
Beijing Municipal Science & Technology Commission, Beijing University of Chinese Medicine
1. Study Identification
Unique Protocol Identification Number
NCT02427347
Brief Title
Acupuncture in the Regulation of Dai Meridian for the Metabolism of Visceral Adipose Tissue in Abdominal Obese Patients
Official Title
A Randomized Controlled Clinical Trial of Acupuncture on Regulating Dai Meridian for Visceral Fat Metabolism in Abdominal Obesity.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
September 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dongfang Hospital Beijing University of Chinese Medicine
Collaborators
Beijing Municipal Science & Technology Commission, Beijing University of Chinese Medicine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To evaluate the effectiveness of acupuncture therapy combined with healthy education for patients with abdominal obesity.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Obesity, Metabolic Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Intervention including acupuncture treatment and healthy education.
Arm Title
Control group
Arm Type
Other
Arm Description
Healthy education is given as a baseline treatment.
Intervention Type
Other
Intervention Name(s)
Acupuncture
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Healthy education
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes from Baseline in abdominal subcutaneous fat thickness at 8 weeks
Description
Including subcutaneous fat thickness 1 and 2
Time Frame
baseline and 8 weeks
Title
Changes from Baseline in abdominal visceral fat thickness at 8 weeks
Description
Including visceral fat thickness 1 and 2
Time Frame
baseline and 8 weeks
Title
Change from Baseline in antero-hepatic fat thickness at 8 weeks
Description
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
Title
Change from Baseline in perirenal fat thickness at 8 weeks
Description
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
Title
Change from Baseline in ultrasound viscerofatty index at 8 weeks
Description
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
Title
Change from Baseline in fasting serum visfatin at 8 weeks
Description
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
Secondary Outcome Measure Information:
Title
Change from Baseline in body weight
Description
It's made at the situation of fasting, after emptying bowels, with minimal clothing, without headdress and footwear, at the end of expiration.
Time Frame
baseline, 4 weeks and 8 weeks
Title
Change from Baseline in body mass index
Description
Body mass index (BMI) = body weight(kg)/height(m)/height(m)
Time Frame
baseline, 4 weeks and 8 weeks
Title
Change from Baseline in waist circumference
Description
WC was measured at the level between the inferior portion of 12th rib and iliac crest.
Time Frame
baseline, 4 weeks and 8 weeks
Title
Change from Baseline in hip circumference
Description
HC was measured at the level of the most prominent point of the pelvis.
Time Frame
baseline, 4 weeks and 8 weeks
Title
Change from Baseline in waist-to-hip radio
Description
waist-to-hip radio (WHR) = waist circumference(cm)/hip circumference(cm)
Time Frame
baseline, 4 weeks and 8 weeks
Title
Change from Baseline in waist-to-height radio
Description
waist-to-height radio (WHtR) = waist circumference(cm)/height(cm)
Time Frame
baseline, 4 weeks and 8 weeks
Title
Change from Baseline in the percentage of body fat
Description
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
Title
Change from Baseline in fasting blood glucose at 8 weeks
Description
5ml venous blood was collected after an 8 hours fast. It was tested by our hospital's laboratory.
Time Frame
baseline and 8 weeks
Title
Change from Baseline in fasting insulin at 8 weeks
Description
5ml venous blood was collected after an 8 hours fast. It was tested by our hospital's laboratory.
Time Frame
baseline and 8 weeks
Title
Change from Baseline in glycosylated hemoglobin at 8 weeks
Description
5ml venous blood was collected after an 8 hours fast. It was tested by our hospital's laboratory.
Time Frame
baseline and 8 weeks
Title
Change from Baseline in fasting total cholesterol at 8 weeks
Description
5ml venous blood was collected after an 8 hours fast. It was tested by our hospital's laboratory.
Time Frame
baseline and 8 weeks
Title
Change from Baseline in fasting triglyceride at 8 weeks
Description
5ml venous blood was collected after an 8 hours fast. It was tested by our hospital's laboratory.
Time Frame
baseline and 8 weeks
Title
Change from Baseline in fasting high density lipoprotein cholesterol at 8 weeks
Description
5ml venous blood was collected after an 8 hours fast. It was tested by our hospital's laboratory.
Time Frame
baseline and 8 weeks
Title
Change from Baseline in fasting low density lipoprotein cholesterol at 8 weeks
Description
5ml venous blood was collected after an 8 hours fast. It was tested by our hospital's laboratory.
Time Frame
baseline and 8 weeks
Title
Change from Baseline in fasting uric acid at 8 weeks
Description
5ml venous blood was collected after an 8 hours fast. It was tested by our hospital's laboratory.
Time Frame
baseline and 8 weeks
Title
Change from Baseline in blood pressure at 8 weeks
Time Frame
baseline and 8 weeks
Title
Change from Baseline in insulin resistance level at 8 weeks
Time Frame
baseline and 8 weeks
Title
Change from Baseline in obesity related lifestyle survey at 8 weeks
Time Frame
baseline and 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hui Hu, doctor
Organizational Affiliation
Department of Acupuncture and Moxibustion, Dongfang Hospital, Beijing University of Chinese Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Acupuncture and Moxibustion, Dongfang Hospital, Beijing University of Chinese Medicine
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100078
Country
China
12. IPD Sharing Statement
Learn more about this trial
Acupuncture in the Regulation of Dai Meridian for the Metabolism of Visceral Adipose Tissue in Abdominal Obese Patients
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