Obesity, Abdominal
Conditions
Keywords
Abdominal obesity, Electro-acupuncture, Randomized controlled trial
Brief summary
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
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.
Interventions
DEVICEElectro-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.
DEVICESham 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.
Sponsors
Hubei Hospital of Traditional Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline waistline at 8 weeks. | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline body mass index at 8 weeks. | 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. |
| Change from baseline the body fat percentage at 8 weeks. | 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). |
| Change from baseline hip circumference at 8 weeks. | 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. |
| Change from baseline waist-to-hip ratio at 8 weeks. | 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 ). |
| Change from baseline body weight at 8 weeks. | week 0,week 4,week 8,week 20,week 32 | Body weight will be measured by a body composition analyzer (OMRON V.BODY). |
| Changes from baseline blood fat at 8 weeks. | week 0, week 8 | Examined with the blood sample. |
| Changes from baseline blood pressure at 8 weeks | week 0,week 4,week 8,week 32 | Both Systolic and diastolic blood pressure assessed by office and ambulatory blood pressure monitoring(mmHg). |
| Changes from baseline the IWQOL - Lite scale score at 8 weeks | 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). |
| Changes from baseline the Kessler 10 scale at 8weeks. | 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. |
| Changes from baseline insulin resistance index at 8 weeks. | week 0, week 8 | Examined with the blood sample. |
Countries
China
Outcome results
None listed