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

NCT04957134 | Completed DMC

• 1 other identifier: ZY2021Z004
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity, Abdominal

Keywords

Abdominal obesity; Electro-acupuncture; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Change from baseline body weight at 8 weeks.

  week 0,week 4,week 8,week 20,week 32

• Change from baseline body mass index at 8 weeks.

  week 0,week 4,week 8,week 20,week 32

• Change from baseline the body fat percentage at 8 weeks.

  week 0,week 8,week 32

• Change from baseline hip circumference at 8 weeks.

  week 0,week 4,week 8,week 20,week 32

• Change from baseline waist-to-hip ratio at 8 weeks.

  week 0,week 4,week 8,week 20,week 32

Study Arms (2)

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.

Device: Electro-acupuncture

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.

Device: Sham electro-acupuncture

Interventions

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.

Electro-acupuncture

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.

Sham electro-acupuncture

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hubei Hospital of Traditional Chinese Medicine: lead

Study Sites (1)

Hubei Provincial Hospital of Traditional Chinese Medicine

Wuhan, Hubei, 430061, China

Location

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MeSH Terms

Conditions

Obesity, Abdominal

Condition Hierarchy (Ancestors)

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

Study Officials

• Zhongyu Zhou, Professor

  Hubei Hospital of Traditional Chinese Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Hubei Provincial Hospital of Traditional Chinese Medicine

Study Record Dates

• First Submitted: June 24, 2021
• First Posted: July 12, 2021
• Study Start: July 22, 2021
• Primary Completion: March 15, 2023
• Study Completion: March 15, 2023
• Last Updated: June 12, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)