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

NCT ID: NCT02427347

Last Updated: 2018-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2017-09-30

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.

Conditions

Abdominal Obesity; Metabolic Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention group

Intervention including acupuncture treatment and healthy education.

Group Type: EXPERIMENTAL

Acupuncture

Intervention Type: 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

Intervention Type: 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.

Control group

Healthy education is given as a baseline treatment.

Group Type: OTHER

Healthy education

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Municipal Science & Technology Commission

OTHER

Sponsor Role: collaborator

Beijing University of Chinese Medicine

OTHER

Sponsor Role: collaborator

Dongfang Hospital Beijing University of Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Hui Hu

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hui Hu, doctor

Role: STUDY_CHAIR

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

Locations

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

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

Z141107002514079

Identifier Type: -

Identifier Source: org_study_id