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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
66
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.
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.
Hubei Provincial Hospital of Traditional Chinese Medicine
Wuhan, Hubei, China
Change from baseline waistline at 8 weeks.
Waistline will be measured around the abdomen at the level of the umbilicus (belly button).
Time frame: week 0,week 4,week 8,week 20,week 32
Change from baseline body weight at 8 weeks.
Body weight will be measured by a body composition analyzer (OMRON V.BODY).
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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 ).
Time frame: week 0,week 4,week 8,week 20,week 32
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Changes from baseline insulin resistance index at 8 weeks.
Examined with the blood sample.
Time frame: week 0, week 8
Changes from baseline blood fat at 8 weeks.
Examined with the blood sample.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: week 0,week 8,week 32