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Completed

NCT Number: NCT02427347

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

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

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Key information

Conditions

Abdominal Obesity Body Weight Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Abdominal Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Beijing, Beijing Municipality, 100078, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Acupuncture

Other

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 education

Other

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Dongfang Hospital Beijing University of Chinese Medicine

Other

Collaborators

  • Beijing Municipal Science & Technology Commission
  • Beijing University of Chinese Medicine

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2017
First posted
Apr 28, 2015
Registry last updated
Aug 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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