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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Obesity, Abdominal

Intervention / Treatment
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* Device: Electro-acupuncture
* Device: Sham electro-acupuncture


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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Electro-acupuncture<br>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<br>* 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.<br>|
| Placebo Comparator: Sham electro-acupuncture<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline waistline at 8 weeks. | 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 |
| --- | --- | --- |
| Change from baseline body weight at 8 weeks. | 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. | 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. | 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. | 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. | 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 insulin resistance index at 8 weeks. | Examined with the blood sample. | week 0, week 8 | 
| Changes from baseline blood fat at 8 weeks. | Examined with the blood sample. | week 0, week 8 | 
| Changes from baseline blood pressure at 8 weeks | 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 | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Abdominal obesity, Electro-acupuncture, Randomized controlled trial