Electro-acupuncture for Central Obesity

Central Obesity Clinical Trial

Official title:

Electro-acupuncture for Central Obesity: a Single Blinded Randomized Sham-controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03815253
• Other study ID #: HKBU-HMRF
• Status: Completed
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: February 28, 2021

Study information

• Verified date: March 2021
• Source: Hong Kong Baptist University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this study, a 8-week, single blinded, randomized controlled clinical trial will be conducted to examine the efficacy and safety of body acupuncture in the treatment of central obesity in Hong Kong.

Description:

This is a pilot single-blind, randomized, sham-controlled trial. 168 central obesity patients will be randomly assigned to acupuncture group or control group. The duration of the treatment will be 8 weeks with 2 session per week and the follow-up period will be 2 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: February 28, 2021
• Est. primary completion date: January 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

Patients who meet all of the following criteria are defined as eligible participants: men and women aged between 18 and 65 years old; BMI = 25 kg/m2; central obesity, defined as WC of = 90 cm in men and = 80 cm in non-pregnant women according to ICD-10 [24]; not receiving any other weight control measures or any medical and/or drug history in last 3months.

Exclusion Criteria:

Patients who meet any of the following criteria should be excluded from the study:

endocrine diseases, including thyroid disorder, pituitary disorder, sex gland disorder, etc.; heart diseases, including arrhythmia, heart failure, myocardial infarction, patients with pacemaker; allergy and immunology diseases; bleeding tendency; pregnant or lactating women; impaired hepatic or renal function; stroke or unable to exercise.

Related Conditions & MeSH terms

• Central Obesity
• Obesity
• Obesity, Abdominal

Intervention

Other:
• acupuncture
Body electro-acupuncture will choose eight acupoints as Tianshu(ST-25), Daheng(SP-15), Daimai(GB-26), Qihai(CV-6), Zhongwan(CV-12), Zusanli (ST-36), Fenlong(ST-40), Sanyinjiao(SP-6).Disposable acupuncture needles (verum acupuncture needles asia-med Special No. 16 with 0.30 x 0.30mm matching the Streitberger sham-needles) will be inserted at a depth of 10-25 mm into the points. We will also deliver electrical stimulation with dense-disperse waves with 50Hz at 10 volts through electrical acupuncture stimulation instrument (ES-160 6-Channel Programmable Electro-acupuncture) to the abdominal points. The bodily needles will be retained for 30 minutes.

Locations

Country	Name	City	State
Hong Kong	Linda Zhong	Kowloon Tong	Kowloon

Sponsors (2)

Lead Sponsor	Collaborator
Hong Kong Baptist University	Princess Margaret Hospital, Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in waist circumference	Waist circumference will be measured around the abdomen at the level of the umbilicus (belly button).	0,1,2,3,4,5,6,7,8, 11, 15,18, 21, 24 weeks
Secondary	Changes in hip circumference	hip circumference measured at the level of maximum posterior extension of the buttocks	0,1,2,3,4,5,6,7,8,9,11,15,18, 21, 24 weeks
Secondary	Adverse events after treatment and follow up	Adverse events of acupuncture treatment will be assessed using the Treatment Emergent Symptom Scale (TESS) and would be evaluated during the whole procedure, as well as laboratory tests (whole blood counts, renal and liver functions) if needed. All clinical adverse events will be recorded in terms of intensity (mild, moderate, or severe), duration, outcome and relationship to the study.	0,1,2,3,4,5,6,7,8, 15,18, 21, 24 weeks
Secondary	Changes in waist-to-hip circumference ratio	waist-to-hip ratio is the dimensionless ratio of the circumference of the waist to that of the hips. This is calculated as waist measurement divided by hip measurement ( W ÷ H ).	0,1,2,3,4,5,6,7,8, 15,18, 21, 24 weeks
Secondary	Changes in Body Mass Index	Body Mass Index is a simple calculation using a person's height and weight. The formula is BMI = kg/m2 where kg is a person's weight in kilograms and m2 is their height in metres squared.	0,1,2,3,4,5,6,7,8, 15,18, 21, 24 weeks
Secondary	Changes in body fat percentage	The body fat percentage (BFP) of a human or other living being is the total mass of fat divided by total body mass, multiplied by 100. Body fat percentage will be measured by Omron Karada Scan HBF-701.	0,1,2,3,4,5,6,7,8, 15,18, 21, 24 weeks
Secondary	Changes in total cholesterol (TC), triglyceride (TG) and fasting blood glucose (FBG)	Total cholesterol (TC), triglyceride (TG) and fasting blood glucose (FBG) will be measured before and after the 8-week treatment.	0, 8 weeks