Skip to main content
OpenTrials
Completed

NCT Number: NCT03815253

Electro-acupuncture for Central Obesity

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Central Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Abdominal Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Linda Zhong

Kowloon Tong, Kowloon, Hong Kong

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Acupuncture

Other

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.

Primary outcomes

  1. Changes in waist circumference

    Time frame: 0,1,2,3,4,5,6,7,8, 11, 15,18, 21, 24 weeks

    Waist circumference will be measured around the abdomen at the level of the umbilicus (belly button).

Secondary outcomes

  1. Changes in hip circumference

    Time frame: 0,1,2,3,4,5,6,7,8,9,11,15,18, 21, 24 weeks

    hip circumference measured at the level of maximum posterior extension of the buttocks

  2. Adverse events after treatment and follow up

    Time frame: 0,1,2,3,4,5,6,7,8, 15,18, 21, 24 weeks

    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.

  3. Changes in waist-to-hip circumference ratio

    Time frame: 0,1,2,3,4,5,6,7,8, 15,18, 21, 24 weeks

    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 ).

  4. Changes in Body Mass Index

    Time frame: 0,1,2,3,4,5,6,7,8, 15,18, 21, 24 weeks

    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.

  5. Changes in body fat percentage

    Time frame: 0,1,2,3,4,5,6,7,8, 15,18, 21, 24 weeks

    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.

  6. Changes in total cholesterol (TC), triglyceride (TG) and fasting blood glucose (FBG)

    Time frame: 0, 8 weeks

    Total cholesterol (TC), triglyceride (TG) and fasting blood glucose (FBG) will be measured before and after the 8-week treatment.

Sponsors and collaborators

Lead sponsor

Hong Kong Baptist University

Other

Collaborators

  • Princess Margaret Hospital, Hong Kong

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jan 24, 2019
Registry last updated
Mar 16, 2021

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.