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

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ClinicalTrials.gov Identifier: NCT02427347
Recruitment Status : Completed
First Posted : April 28, 2015
Last Update Posted : August 17, 2018
Sponsor:
Collaborators:
Beijing Municipal Science & Technology Commission
Beijing University of Chinese Medicine
Information provided by (Responsible Party):
Hui Hu, Dongfang Hospital Beijing University of Chinese Medicine

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

Condition or disease Intervention/treatment Phase
Abdominal Obesity Metabolic Syndrome Other: Acupuncture Other: Healthy education Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Clinical Trial of Acupuncture on Regulating Dai Meridian for Visceral Fat Metabolism in Abdominal Obesity.
Study Start Date : June 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture

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.

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.




Primary Outcome Measures :
  1. Changes from Baseline in abdominal subcutaneous fat thickness at 8 weeks [ Time Frame: baseline and 8 weeks ]
    Including subcutaneous fat thickness 1 and 2

  2. Changes from Baseline in abdominal visceral fat thickness at 8 weeks [ Time Frame: baseline and 8 weeks ]
    Including visceral fat thickness 1 and 2

  3. Change from Baseline in antero-hepatic fat thickness at 8 weeks [ Time Frame: baseline and 8 weeks ]
    Antero-hepatic fat thickness (AHF) was determined by the distance of peritoneum to the hepatic cortex at the subcostal level.

  4. Change from Baseline in perirenal fat thickness at 8 weeks [ Time Frame: 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.

  5. Change from Baseline in ultrasound viscerofatty index at 8 weeks [ Time Frame: baseline and 8 weeks ]
    ultrasound viscerofatty index (UVI) = (visceral fat thickness 1 + visceral fat thickness2)/(subcutaneous fat thickness 1 + subcutaneous fat thickness 2)

  6. Change from Baseline in fasting serum visfatin at 8 weeks [ Time Frame: baseline and 8 weeks ]
    5ml venous blood was told after an 8 hours fast. Visfatin was measured by enzyme-linkedimmuno sorbent assay (ELISA).


Secondary Outcome Measures :
  1. Change from Baseline in body weight [ Time Frame: baseline, 4 weeks and 8 weeks ]
    It's made at the situation of fasting, after emptying bowels, with minimal clothing, without headdress and footwear, at the end of expiration.

  2. Change from Baseline in body mass index [ Time Frame: baseline, 4 weeks and 8 weeks ]
    Body mass index (BMI) = body weight(kg)/height(m)/height(m)

  3. Change from Baseline in waist circumference [ Time Frame: baseline, 4 weeks and 8 weeks ]
    WC was measured at the level between the inferior portion of 12th rib and iliac crest.

  4. Change from Baseline in hip circumference [ Time Frame: baseline, 4 weeks and 8 weeks ]
    HC was measured at the level of the most prominent point of the pelvis.

  5. Change from Baseline in waist-to-hip radio [ Time Frame: baseline, 4 weeks and 8 weeks ]
    waist-to-hip radio (WHR) = waist circumference(cm)/hip circumference(cm)

  6. Change from Baseline in waist-to-height radio [ Time Frame: baseline, 4 weeks and 8 weeks ]
    waist-to-height radio (WHtR) = waist circumference(cm)/height(cm)

  7. Change from Baseline in the percentage of body fat [ Time Frame: baseline, 4 weeks and 8 weeks ]
    the percentage of body fat = 1.2×BMI+0.23×age-5.4-10.8×gender(M=1,F=0)

  8. Change from Baseline in fasting blood glucose at 8 weeks [ Time Frame: baseline and 8 weeks ]
    5ml venous blood was collected after an 8 hours fast. It was tested by our hospital's laboratory.

  9. Change from Baseline in fasting insulin at 8 weeks [ Time Frame: baseline and 8 weeks ]
    5ml venous blood was collected after an 8 hours fast. It was tested by our hospital's laboratory.

  10. Change from Baseline in glycosylated hemoglobin at 8 weeks [ Time Frame: baseline and 8 weeks ]
    5ml venous blood was collected after an 8 hours fast. It was tested by our hospital's laboratory.

  11. Change from Baseline in fasting total cholesterol at 8 weeks [ Time Frame: baseline and 8 weeks ]
    5ml venous blood was collected after an 8 hours fast. It was tested by our hospital's laboratory.

  12. Change from Baseline in fasting triglyceride at 8 weeks [ Time Frame: baseline and 8 weeks ]
    5ml venous blood was collected after an 8 hours fast. It was tested by our hospital's laboratory.

  13. Change from Baseline in fasting high density lipoprotein cholesterol at 8 weeks [ Time Frame: baseline and 8 weeks ]
    5ml venous blood was collected after an 8 hours fast. It was tested by our hospital's laboratory.

  14. Change from Baseline in fasting low density lipoprotein cholesterol at 8 weeks [ Time Frame: baseline and 8 weeks ]
    5ml venous blood was collected after an 8 hours fast. It was tested by our hospital's laboratory.

  15. Change from Baseline in fasting uric acid at 8 weeks [ Time Frame: baseline and 8 weeks ]
    5ml venous blood was collected after an 8 hours fast. It was tested by our hospital's laboratory.

  16. Change from Baseline in blood pressure at 8 weeks [ Time Frame: baseline and 8 weeks ]
  17. Change from Baseline in insulin resistance level at 8 weeks [ Time Frame: baseline and 8 weeks ]
  18. Change from Baseline in obesity related lifestyle survey at 8 weeks [ Time Frame: baseline and 8 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02427347


Locations
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China, Beijing
Department of Acupuncture and Moxibustion, Dongfang Hospital, Beijing University of Chinese Medicine
Beijing, Beijing, China, 100078
Sponsors and Collaborators
Dongfang Hospital Beijing University of Chinese Medicine
Beijing Municipal Science & Technology Commission
Beijing University of Chinese Medicine
Investigators
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Study Chair: Hui Hu, doctor Department of Acupuncture and Moxibustion, Dongfang Hospital, Beijing University of Chinese Medicine
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Responsible Party: Hui Hu, Principal Investigator, Dongfang Hospital Beijing University of Chinese Medicine
ClinicalTrials.gov Identifier: NCT02427347    
Other Study ID Numbers: Z141107002514079
First Posted: April 28, 2015    Key Record Dates
Last Update Posted: August 17, 2018
Last Verified: August 2018
Additional relevant MeSH terms:
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Obesity
Metabolic Syndrome
Obesity, Abdominal
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases