Efficacy of Electro-acupuncture for Abdominal Obesity: Study for a Randomized Controlled Trial

June 9, 2023 updated by: Wang Jian, Hubei Hospital of Traditional Chinese Medicine

The Efficacy and Safety of Electro-acupuncture for Abdominal Obesity: Original Study for a Multicenter, Randomized, Sham-controlled Trial

Electro-acupuncture provides stimulation to acupoints, and has been widely used to treat abdominal obesity in China despite of lack of high-level evidence for treatment efficacy. The study will investigate whether the electroacupuncture can alleviate clinical symptoms and the mechanism of action in patients with abdominal obesity.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study will be a randomized controlled trial from May 2021 to December 2022, including 68 participants with abdominal obesity. The participants will be randomly divided into 2 groups in a 1:1 allocation ratio.The intervention group will receive electroacupuncture; the control group will receive sham acupuncture. Each treatment will last 12 weeks, including 8 weeks of intervention period and 24 weeks of follow-up. The primary outcome is the waist circumference (WC), the secondary outcomes include weight, body mass index (BMI), hipline, waist-hip-ratio (WHR), Insulin resistance index (IRI), blood fat, metabolomics will be used analysis the mechanism. The adverse events will be recorded during the intervention and follow-up period.

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430061
        • Hubei Provincial Hospital of Traditional Chinese Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients recruited for this study should meet the following inclusion criteria:

    1.Satisfying the criteria for the diagnosis of abdominal obesity; 2.18 years old≤age≤55 years old; 3.Being able to fully understand and voluntarily sign informed consent.

Exclusion Criteria:

  • Patients with any of the following criteria will be excluded from the study:

    1. Presence of endocrine disorders such as: polycystic ovary syndrome; Cushing's syndrome; uncorrected thyroid disease.
    2. Presence of diabetes mellitus, or hypertension, or abnormal liver and kidney functions, or mental diseases.
    3. Pregnant or lactating state, women who plan to become pregnant within 12 weeks.
    4. History of bulimia, anorexia, or any other eating disorders.
    5. Use of medications in the past 3 months, such as diet drugs, corticosteroids, antidepressants, which may affect weight or appetite.
    6. History of surgical weight loss, postoperative adhesions.
    7. History of participating in a clinical study of weight loss or any other therapies to lose weight in the past 3 months.
    8. Unable to cooperate with the research caused by other diseases or reasons.
    9. Received acupuncture within 6 months before enrollment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Electro-acupuncture
Participants will receive electro-acupuncture combined with lifestyle intervention. Participants will receive the treatment of electroacupuncture 3 times a week to fulfill a 8-session treatment course.
Device: Electro-acupuncture
The acupoints of electro-acupuncture will be selected as Zusanli ,Sanyinjiao ,Zhongwan , Tianshu , Shuifen , Daheng ,Daimai , Shuidao ,Huaroumen and Fujie . We will deliver electrical stimulation with dense-disperse waves at 50 Hz and 10 V through the electrical acupuncture stimulation instrument to the abdominal points. The bodily needles will be retained for 30 minutes . Electro-acupuncture treatment will be applied 3 times a week, once every other day, for 8 consecutive weeks.
Placebo Comparator: Sham electro-acupuncture
Participants will receive the treatment of sham electro-acupuncture 3 times a week to fulfill a 8-session treatment course, A superficial skin penetration (2-3 mm in depth) at nonacupoints will be performed in the sham acupuncture group, without needle manipulation for De qi. The internal output power cord of the electrical acupuncture stimulation instrument is interrupted.
Device: Sham electro-acupuncture
The acupoints of sham electro-acupuncture will be selected as nonacupoints . The internal output power cord of the electrical acupuncture stimulation instrument will be interrupted. The bodily needles will be retained for 30 minutes . Sham acupuncture treatment will be applied 3 times a week, once every other day, for 8 consecutive weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline waistline at 8 weeks.
Time Frame: week 0,week 4,week 8,week 20,week 32
Waistline will be measured around the abdomen at the level of the umbilicus (belly button).
week 0,week 4,week 8,week 20,week 32

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes from baseline insulin resistance index at 8 weeks.
Time Frame: week 0, week 8
Examined with the blood sample.
week 0, week 8
Changes from baseline blood fat at 8 weeks.
Time Frame: week 0, week 8
Examined with the blood sample.
week 0, week 8
Change from baseline body weight at 8 weeks.
Time Frame: week 0,week 4,week 8,week 20,week 32
Body weight will be measured by a body composition analyzer (OMRON V.BODY).
week 0,week 4,week 8,week 20,week 32
Change from baseline body mass index at 8 weeks.
Time Frame: week 0,week 4,week 8,week 20,week 32
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.
week 0,week 4,week 8,week 20,week 32
Change from baseline the body fat percentage at 8 weeks.
Time Frame: week 0,week 8,week 32
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 a body composition analyzer (OMRON V.BODY).
week 0,week 8,week 32
Change from baseline hip circumference at 8 weeks.
Time Frame: week 0,week 4,week 8,week 20,week 32
Hip circumference will be measured at the level of maximum posterior extension of the buttocks.
week 0,week 4,week 8,week 20,week 32
Change from baseline waist-to-hip ratio at 8 weeks.
Time Frame: week 0,week 4,week 8,week 20,week 32
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 ).
week 0,week 4,week 8,week 20,week 32
Changes from baseline blood pressure at 8 weeks
Time Frame: week 0,week 4,week 8,week 32
Both Systolic and diastolic blood pressure assessed by office and ambulatory blood pressure monitoring(mmHg).
week 0,week 4,week 8,week 32
Changes from baseline the IWQOL - Lite scale score at 8 weeks
Time Frame: week 0,week 8,week 32
Quality of life was examined using the Impact of Weight on Quality of Life (IWQOL) questionnaire, which has a score range from 0(worst) to 100(best).
week 0,week 8,week 32
Changes from baseline the Kessler 10 scale at 8weeks.
Time Frame: week 0,week 8,week 32
10 item self-report measure of psychological distress with five response categories (none of the time, a little of the time, some of the time, most of the time, all of the time). Scores range from 10 to 50; a higher score indicates more psychological distress.
week 0,week 8,week 32

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hubei Hospital of Traditional Chinese Medicine

Investigators

  • Principal Investigator: Zhongyu Zhou, Professor, Hubei Hospital of Traditional Chinese Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 22, 2021

Primary Completion (Actual)

March 15, 2023

Study Completion (Actual)

March 15, 2023

Study Registration Dates

First Submitted

June 24, 2021

First Submitted That Met QC Criteria

June 30, 2021

First Posted (Actual)

July 12, 2021

Study Record Updates

Last Update Posted (Actual)

June 12, 2023

Last Update Submitted That Met QC Criteria

June 9, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZY2021Z004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The overall data outcome will be published in the form of public paper before december 2024.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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