Clinical trial NCT04957134: Efficacy of Electro-acupuncture for Abdominal Obesity: Study for a Randomized Controlled Trial
Official title: The Efficacy and Safety of Electro-acupuncture for Abdominal Obesity: Original Study for a Multicenter, Randomized, Sham-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity, Abdominal
Keywords: Abdominal obesity
Electro-acupuncture
Randomized controlled trial
Lead sponsor: Hubei Hospital of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2021-07-12
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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:

  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

Primary outcomes:
measure: Change from baseline waistline at 8 weeks.
timeFrame: week 0,week 4,week 8,week 20,week 32
Secondary outcomes:
measure: Change from baseline body weight at 8 weeks.
timeFrame: week 0,week 4,week 8,week 20,week 32
measure: Change from baseline body mass index at 8 weeks.
timeFrame: week 0,week 4,week 8,week 20,week 32
measure: Change from baseline the body fat percentage at 8 weeks.
timeFrame: week 0,week 8,week 32
measure: Change from baseline hip circumference at 8 weeks.
timeFrame: week 0,week 4,week 8,week 20,week 32
measure: Change from baseline waist-to-hip ratio at 8 weeks.
timeFrame: week 0,week 4,week 8,week 20,week 32
measure: Changes from baseline insulin resistance index at 8 weeks.
timeFrame: week 0, week 8
measure: Changes from baseline blood fat at 8 weeks.
timeFrame: week 0, week 8
measure: Changes from baseline blood pressure at 8 weeks
timeFrame: week 0,week 4,week 8,week 32
measure: Changes from baseline the IWQOL - Lite scale score at 8 weeks
timeFrame: week 0,week 8,week 32
measure: Changes from baseline the Kessler 10 scale at 8weeks.
timeFrame: week 0,week 8,week 32
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Hubei Provincial Hospital of Traditional Chinese Medicine
state: Hubei
Study officials:
affiliation: Hubei Hospital of Traditional Chinese Medicine
name: Zhongyu Zhou, Professor
role: PRINCIPAL_INVESTIGATOR
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