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.
1 other identifier
interventional
120
1 country
1
Brief Summary
To evaluate the effectiveness of acupuncture therapy combined with healthy education for patients with abdominal obesity.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 13, 2015
CompletedFirst Posted
Study publicly available on registry
April 28, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2017
CompletedAugust 17, 2018
August 1, 2018
10 months
April 13, 2015
August 16, 2018
Conditions
Outcome Measures
Primary Outcomes (6)
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 Outcomes (18)
Change from Baseline in body weight
baseline, 4 weeks and 8 weeks
Change from Baseline in body mass index
baseline, 4 weeks and 8 weeks
Change from Baseline in waist circumference
baseline, 4 weeks and 8 weeks
Change from Baseline in hip circumference
baseline, 4 weeks and 8 weeks
Change from Baseline in waist-to-hip radio
baseline, 4 weeks and 8 weeks
- +13 more secondary outcomes
Study Arms (2)
Intervention group
EXPERIMENTALIntervention including acupuncture treatment and healthy education.
Control group
OTHERHealthy education is given as a baseline treatment.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Acupuncture and Moxibustion, Dongfang Hospital, Beijing University of Chinese Medicine
Beijing, Beijing Municipality, 100078, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Hui Hu, doctor
Department of Acupuncture and Moxibustion, Dongfang Hospital, Beijing University of Chinese Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 13, 2015
First Posted
April 28, 2015
Study Start
June 1, 2014
Primary Completion
April 1, 2015
Study Completion
September 1, 2017
Last Updated
August 17, 2018
Record last verified: 2018-08