The Efficacy and Safety of Electro-acupuncture for Abdominal Obesity: Original Study for a Multicenter, Randomized, Sham-controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Obesity, Abdominal
- Sponsor
- Hubei Hospital of Traditional Chinese Medicine
- Enrollment
- 66
- Locations
- 1
- Primary Endpoint
- Change from baseline waistline at 8 weeks.
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Wang Jian
Hubei Provincial Hospital of Traditional Chinese Medicine
Hubei Hospital of Traditional Chinese Medicine
Eligibility Criteria
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
Outcomes
Primary Outcomes
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
- 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 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)
- Changes from baseline insulin resistance index at 8 weeks.(week 0, week 8)
- Changes from baseline blood fat at 8 weeks.(week 0, week 8)
- Changes from baseline the Kessler 10 scale at 8weeks.(week 0,week 8,week 32)
- Changes from baseline blood pressure at 8 weeks(week 0,week 4,week 8,week 32)
- Changes from baseline the IWQOL - Lite scale score at 8 weeks(week 0,week 8,week 32)
- Change from baseline the body fat percentage at 8 weeks.(week 0,week 8,week 32)