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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Electro-acupuncture | Experimental | 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. |
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| Sham electro-acupuncture | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electro-acupuncture | Device | 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. |
| 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 |
| 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. |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Zhongyu Zhou, Professor | Hubei Hospital of Traditional Chinese Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hubei Provincial Hospital of Traditional Chinese Medicine | Wuhan | Hubei | 430061 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29856171 | Background | Carbone A, Al Salhi Y, Tasca A, Palleschi G, Fuschi A, De Nunzio C, Bozzini G, Mazzaferro S, Pastore AL. Obesity and kidney stone disease: a systematic review. Minerva Urol Nefrol. 2018 Aug;70(4):393-400. doi: 10.23736/S0393-2249.18.03113-2. Epub 2018 May 31. | |
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The overall data outcome will be published in the form of public paper before december 2024.
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| ID | Term |
|---|---|
| D056128 | Obesity, Abdominal |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| Sham electro-acupuncture | Device | 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. |
|
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 |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |