Clinical trial NCT03815253: Electro-acupuncture for Central Obesity
Official title: Electro-acupuncture for Central Obesity: a Single Blinded Randomized Sham-controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Central Obesity
Lead sponsor: Hong Kong Baptist University
Sponsor class: OTHER
Collaborators: name: Princess Margaret Hospital, Hong Kong
First posted: 2019-01-24
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: single-blinded, randomized, sham-controlled clinical trial
Primary purpose: TREATMENT

Brief summary: In this study, a 8-week, single blinded, randomized controlled clinical trial will be conducted to examine the efficacy and safety of body acupuncture in the treatment of central obesity in Hong Kong.

Detailed description: This is a pilot single-blind, randomized, sham-controlled trial. 168 central obesity patients will be randomly assigned to acupuncture group or control group. The duration of the treatment will be 8 weeks with 2 session per week and the follow-up period will be 2 weeks.

Eligibility criteria: Inclusion Criteria:

Patients who meet all of the following criteria are defined as eligible participants: men and women aged between 18 and 65 years old; BMI ≥ 25 kg/m2; central obesity, defined as WC of ≥ 90 cm in men and ≥ 80 cm in non-pregnant women according to ICD-10 \[24\]; not receiving any other weight control measures or any medical and/or drug history in last 3months.

Exclusion Criteria:

Patients who meet any of the following criteria should be excluded from the study: endocrine diseases, including thyroid disorder, pituitary disorder, sex gland disorder, etc.; heart diseases, including arrhythmia, heart failure, myocardial infarction, patients with pacemaker; allergy and immunology diseases; bleeding tendency; pregnant or lactating women; impaired hepatic or renal function; stroke or unable to exercise.

Primary outcomes:
measure: Changes in waist circumference
timeFrame: 0,1,2,3,4,5,6,7,8, 11, 15,18, 21, 24 weeks
Secondary outcomes:
measure: Changes in hip circumference
timeFrame: 0,1,2,3,4,5,6,7,8,9,11,15,18, 21, 24 weeks
measure: Adverse events after treatment and follow up
timeFrame: 0,1,2,3,4,5,6,7,8, 15,18, 21, 24 weeks
measure: Changes in waist-to-hip circumference ratio
timeFrame: 0,1,2,3,4,5,6,7,8, 15,18, 21, 24 weeks
measure: Changes in Body Mass Index
timeFrame: 0,1,2,3,4,5,6,7,8, 15,18, 21, 24 weeks
measure: Changes in body fat percentage
timeFrame: 0,1,2,3,4,5,6,7,8, 15,18, 21, 24 weeks
measure: Changes in total cholesterol (TC), triglyceride (TG) and fasting blood glucose (FBG)
timeFrame: 0, 8 weeks
Other outcomes:
Locations:
city: Kowloon Tong
country: Hong Kong
facility: Linda Zhong
state: Kowloon
Study officials:
affiliation: Hong Kong Chinese Medicine Clinical Study Centre
name: Zhaoxiang Bian, MD., Ph.D
role: STUDY_DIRECTOR
References:
citation: Zhong LLD, Wu X, Lam TF, Wong YP, Cao P, Wong EY, Zhang S, Bian Z. Electro-acupuncture for central obesity: randomized, patient-assessor blinded, sham-controlled clinical trial protocol. BMC Complement Med Ther. 2021 Jul 3;21(1):190. doi: 10.1186/s12906-021-03367-2.