Clinical trial NCT02427347: 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
Overall status: COMPLETED
Phase: NA
Conditions: Abdominal Obesity
Metabolic Syndrome
Lead sponsor: Dongfang Hospital Beijing University of Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Beijing Municipal Science & Technology Commission
name: Beijing University of Chinese Medicine
First posted: 2015-04-28
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Changes from Baseline in abdominal subcutaneous fat thickness at 8 weeks
timeFrame: baseline and 8 weeks
measure: Changes from Baseline in abdominal visceral fat thickness at 8 weeks
timeFrame: baseline and 8 weeks
measure: Change from Baseline in antero-hepatic fat thickness at 8 weeks
timeFrame: baseline and 8 weeks
measure: Change from Baseline in perirenal fat thickness at 8 weeks
timeFrame: baseline and 8 weeks
measure: Change from Baseline in ultrasound viscerofatty index at 8 weeks
timeFrame: baseline and 8 weeks
measure: Change from Baseline in fasting serum visfatin at 8 weeks
timeFrame: baseline and 8 weeks
Secondary outcomes:
measure: Change from Baseline in body weight
timeFrame: baseline, 4 weeks and 8 weeks
measure: Change from Baseline in body mass index
timeFrame: baseline, 4 weeks and 8 weeks
measure: Change from Baseline in waist circumference
timeFrame: baseline, 4 weeks and 8 weeks
measure: Change from Baseline in hip circumference
timeFrame: baseline, 4 weeks and 8 weeks
measure: Change from Baseline in waist-to-hip radio
timeFrame: baseline, 4 weeks and 8 weeks
measure: Change from Baseline in waist-to-height radio
timeFrame: baseline, 4 weeks and 8 weeks
measure: Change from Baseline in the percentage of body fat
timeFrame: baseline, 4 weeks and 8 weeks
measure: Change from Baseline in fasting blood glucose at 8 weeks
timeFrame: baseline and 8 weeks
measure: Change from Baseline in fasting insulin at 8 weeks
timeFrame: baseline and 8 weeks
measure: Change from Baseline in glycosylated hemoglobin at 8 weeks
timeFrame: baseline and 8 weeks
measure: Change from Baseline in fasting total cholesterol at 8 weeks
timeFrame: baseline and 8 weeks
measure: Change from Baseline in fasting triglyceride at 8 weeks
timeFrame: baseline and 8 weeks
measure: Change from Baseline in fasting high density lipoprotein cholesterol at 8 weeks
timeFrame: baseline and 8 weeks
measure: Change from Baseline in fasting low density lipoprotein cholesterol at 8 weeks
timeFrame: baseline and 8 weeks
measure: Change from Baseline in fasting uric acid at 8 weeks
timeFrame: baseline and 8 weeks
measure: Change from Baseline in blood pressure at 8 weeks
timeFrame: baseline and 8 weeks
measure: Change from Baseline in insulin resistance level at 8 weeks
timeFrame: baseline and 8 weeks
measure: Change from Baseline in obesity related lifestyle survey at 8 weeks
timeFrame: baseline and 8 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Acupuncture and Moxibustion, Dongfang Hospital, Beijing University of Chinese Medicine
state: Beijing
Study officials:
affiliation: Department of Acupuncture and Moxibustion, Dongfang Hospital, Beijing University of Chinese Medicine
name: Hui Hu, doctor
role: STUDY_CHAIR
References: