Clinical trial NCT06316310: Effect of Acupoint Thread Embedding on Obesity
Official title: The Effect and Safety of Acupoint Thread Embedding on Over-weight and Obesity Treatment : A Randomized, Single-Blind, Sham- Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Keywords: Acupoint Thread Embedding
Sham Acupoint Thread Embedding
Obesity
Randomized Controlled Trial
Lead sponsor: Shanghai Municipal Hospital of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2024-03-18
Enrollment: 132
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All eligible participants will be randomly assigned into two group at a ratio of 1:1, the Acupoint Thread Embedding group and the Sham Acupoint Thread Embedding group (the control group).

group).
Primary purpose: TREATMENT

Brief summary: The investigators describe a protocol for a randomized controlled trial to find out the effect and safety of acupoint thread embedding on losing weight in obese patients.

Detailed description: Obesity refers to a complex chronic disease in which there is excessive accumulation of body fat. As of 2016, there were more than 650 million obese people worldwide, and it is expected to reach 1.12 billion by 2030, with at least 2.8 million deaths due to obesity each year, according to surveys. In Europe, 60 percent of the population is already overweight or obese. The incidence of obesity is also increasing rapidly in China, with a recent report by The Lancet showing that the number of obese people in China has reached 85 million, making it the country with the highest number of obese people in the world. In 2002, the China Obesity Task Force recommended threshold value to define overweight as Body Mass Index (BMI) of ≥ 24 kg/m2, a waist circumference (WC) ≥of 85 cm for men and a WC ≥ 80 cm for women, or a Waist-to-Hip Ratio (WHR) of ≥ 0.9 for men and a WHR ≥ 0.8 for women, and to define obesity as a BMI ≥ 28 kg/m2. Studies have shown that Asian populations have higher health risks at the same BMI and WC levels due to the distribution of adipose tissue. Acupoint thread embedding is a widely recognized therapy to lose weight in clinical practice.But there are some doubts about the effectiveness of acupoint thread embedding versus sham acupoint thread embedding in treating obesity due to its lack of medical evidence.

This randomized placebo-controlled clinical trial is aimed to investigate the effect and safety of acupoint thread embedding (ATE) in obese patients. The investigators designed a protocol for a randomized controlled trial, in which 132 eligible patients will be randomly assigned to one of the two groups: the ATE group (receiving ATE treatment with health education) and the sham acupoint thread embedding (SATE) group (receiving SATE treatment with health education). A total of 6 sessions of interventions will be given for consecutive 12 weeks, followed by 12 weeks follow-up period. Each session of ATE or SATE treatment will last for about 30 minutes. The primary outcome is the change of the body mass index (BMI) at week 12. The secondary outcomes include the change of patient's body weight and body circumference, results from the blood tests (FBG, LDL-C, HDL-C, TG and TC), the abdominal visceral fat tissue thickness scanned by FibroScan, data collected from the body composition analyzer, and the scores of the impact of weight on quality of life (IWQOL-Lite), the well-being index (WHO-5), visual analog scale (VAS) of appetite and hamilton anxiety scale(HAMA). All adverse effects will be accessed by the treatment emergent symptom scale (TESS) from baseline to the follow-up period. The body weight and circumferences，BMI，IWQOL-Lite, WHO-5, VAS, and the HAMA, will be calculated at baseline, week 6, week 12, and week 24. blood tests，FibroScan and the body composition analyzer's data will be calculated at baseline，week 12 and week24. All patients will be provided with the same health education brochure to choose more beneficial personalized lifestyle during the 12-week intervention period.

All analyses will be performed on the intention-to-treat (ITT) population of participants who have at least one treatment. Missing data will be handled using the multiple imputation method, on the assumption that values at each time point follow a specific distribution calculated by the computer software R V.3.5. The primary outcome is the change of the body mass index (BMI) at week 12. Linear mixed effects models will be used for analyses with the use of the statistical software SPSS V.29.0. The t-test will be used to compare the measurement data between either two groups from the baseline to follow-up; the rank sum test will be used for ranked data while the Chi-squared test will be used to analyze categorical data. The significance level that will be used for statistical analysis with 2-tailed testing will be 2.5%. Data values will mainly be presented as Mean±SD. The findings from this trial will help further explore the efficacy and safety of ATE on losing weight for patients with obesity, as well as determine the differences between the ATE and SATE treatment.

Eligibility criteria: Inclusion Criteria:

* Females aged 18\~45 years old;
* BMI≥24.0 kg/m2；
* WC≥80cm ; recommended BMI and WC threshold value to define overweight in China;
* Stable weight change (increase or decrease of ≤4 kg) within 3 months prior to the start of the test;
* Agree to participate in the trial and sign a written informed consent form;

Exclusion Criteria:

* Secondary obesity caused by drugs, or neuro-endocrine-metabolic disorders (such as thalamic disease, hypopituitarism, etc.);
* History of bariatric surgery (gastric reduction, liposuction, etc.);
* Are taking medications that may affect the results of the trial (weight):
* Severe ulcers, abscesses, skin infections, etc. at the acupuncture site;
* Severe heart, brain, lung, liver and kidney insufficiency, hematopoietic system disease or other serious diseases;
* Participated in other clinical medical trial studies in the past 1 month;
* History of acupoint thread embedding in the past 6 months;
* Alcoholism, drug abuse, or smoking (change in smoking habits within the past 2 months or a plan to quit smoking during the study period);
* Pregnant and lactating women.

Primary outcomes:
measure: Body Mass Index (BMI)
timeFrame: week12
Secondary outcomes:
measure: Change in body weight
timeFrame: week0, week6, week12, week24
measure: Body Mass Index (BMI)
timeFrame: week0, week6, week24
measure: Changes in body circumference
timeFrame: week0, week6, week12, week24
measure: Body composition analysis
timeFrame: week0, week12, week24
measure: Changes in liver fat content
timeFrame: week0, week12, week24
measure: Fasting blood glucose (FPG)
timeFrame: week0, week12, week24
measure: Blood lipid profile
timeFrame: week0, week12, week24
measure: Impact of Weight on Quality-of-Life Scale (IWQOL-Lite)
timeFrame: week0, week6, week12, week24
measure: Well-Being Index (WHO-5)
timeFrame: week0, week6, week12, week24
measure: Visual analog scale (VAS) of appetite
timeFrame: week0, week6, week12, week24
measure: Hamilton Anxiety Scale (HAMA)
timeFrame: week0, week6, week12, week24
measure: Adverse effects
timeFrame: week6, week12, week24
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Municipal Hospital of Traditional Chinese Medicine
state: Shanghai
Study officials:
References: