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NCT Number: NCT04957134

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

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Key information

Conditions

Obesity, Abdominal Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hubei Provincial Hospital of Traditional Chinese Medicine

Wuhan, Hubei, 430061, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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).

  2. 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.

  3. 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).

  4. 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.

  5. 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 ).

  6. Changes from baseline insulin resistance index at 8 weeks.

    Time frame: week 0, week 8

    Examined with the blood sample.

  7. Changes from baseline blood fat at 8 weeks.

    Time frame: week 0, week 8

    Examined with the blood sample.

  8. 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).

  9. 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).

  10. 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.

Sponsors and collaborators

Lead sponsor

Hubei Hospital of Traditional Chinese Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jul 12, 2021
Registry last updated
Jun 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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