Efficacy and Safety of Thread Embedding Acupuncture Therapy for Weight Loss in Adults with Overweight or Obesity
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Relative change in body weight
研究概览
简要总结
Obesity is the most prevalent chronic disease worldwide, affecting approximately 800 million adults. Excess adiposity and its numerous complications, including cardiovascular disease and type 2 diabetes, impose a considerable economic burden and constitute major contributors to global morbidity and mortality. Treatments that result in substantial weight reductions may improve outcomes for people living with obesity. Thread embedding acupuncture which provides long-term acupoints stimulation may be an effective treatment option for obesity. However, effects of thread embedding on obesity remain uncertain because of the small sample sizes or other methodological limitations. The objective of this multi-center, randomized, sham-controlled trial is to assess the effect of thread embedding acupuncture for alleviating weight.
详细描述
The present multi-center, randomized, sham-controlled, parallel-group trial aims to evaluate the effect of thread embedding acupuncture in patients with obesity.
The patients will be randomized to receive one of two treatment arms: thread embedding acupuncture and sham thread embedding acupuncture. The participants will receive treatment that consists of 18 thread embedding acupuncture or sham thread embedding acupuncture sessions over a 24-week period after baseline (once a week for the first 12 weeks and every two weeks for the next 12 weeks). At the end of 24 weeks treatment, the change of weight in overweight/obese participants between the two groups will be analyzed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body-mass index: a. BMI ≥ 28 kg/m2 or b. BMI ≥ 24 kg/m2 with the presence of at least one of the following weight-related complications (treated or untreated): diabetes, hypertension, lipid metabolism disorders, obstructive sleep apnea, cardiovascular disease, knee osteoarthritis, hyperuricemia, fatty liver;
- •Male or female, age between 18 and 75 years at the time of signing informed consent;
- •No history of receiving thread embedding treatment;
- •History of at least one self-reported unsuccessful dietary effort and exercise program to lose body weight;
- •Informed consent obtained.
排除标准
- •A self-reported change in body weight ≥ 5 kg within 90 days before screening;
- •Treatment with any medication for the indication of obesity within the past 90 days before Screening;
- •Previous or planned (during the trial period) obesity treatment with surgery or a bodyweight loss device. However, the following were allowed: (1) liposuction and/or abdominoplasty, if performed more than 1 year before screening; (2) lap banding, if the band had been removed more than 1 year before screening; (3) intragastric balloon, if the balloon had been removed more than 1 year before screening; or (4) duodenal-jejunal bypass sleeve, if the sleeve had been removed more than 1 year before screening;
- •Have obesity induced by other endocrinologic disorders (for example, Cushing Syndrome) or diagnosed monogenetic or syndromic forms of obesity (for example, Melanocortin 4 Receptor deficiency or Prader Willi Syndrome);
- •Uncontrolled thyroid disease, defined as thyroid stimulating hormone (TSH)>6.0 mIU/L or <0.35 mIU/L as measured by the central laboratory at screening;
- •Diagnosed with type 2 diabetes mellitus ≤180 days prior to the day of screening or those who have taken treatment with oral agents that were unstable (different drug(s), dose, or dosing frequency) within the 90 days prior to screening;
- •Receipt of any acupuncture treatment for obesity within 90 days before screening;
- •Participation in any structured, monitored weight-loss program within 90 days before screening;
- •Active inflammatory bowel disease, celiac disease, chronic pancreatitis, or other disorder potentially causing malabsorption;
- •Any of the following severe cardiovascular diseases: myocardial infarction, stroke, heart failure, symptomatic peripheral vascular diseases, or hospitalization for unstable angina or transient ischemic attack within the last 6 months prior to screening;
- •History of malignant neoplasms within the past 5 years prior to screening. Basal and squamous cell skin cancer and any carcinoma in-situ are allowed;
- •Chronic respiratory, neurological, musculoskeletal or other disorders where, in the judgement of the investigator, participants would have unacceptable risk or difficulty in complying with the protocol;
- •Surgery scheduled for the duration of the trial, except for minor surgical procedures, in the opinion of the investigator;
- •Known or suspected abuse of alcohol or recreational drugs;
- •Female who was pregnant, breast-feeding, or intended to become pregnant, or was of child-bearing potential and not using a highly effective contraceptive method;
- •Known or suspected hypersensitivity to trial product or related products;
- •Participation in another clinical trial within 90 days before screening;
- •Any disorder, unwillingness, or inability, not covered by any of the other exclusion criteria, which in the investigator's opinion might have jeopardised the participant's safety or compliance with the protocol.
研究组 & 干预措施
Thread embedding acupuncture
The participants in the thread embedding acupuncture therapy group will receive treatment that consists of 18 thread embedding acupuncture sessions over a 24-week period after baseline (once a week for the first 12 weeks and every two weeks for the next 12 weeks).
干预措施: Thread embedding acupuncture (Other)
Sham thread embedding acupuncture
The participants in the sham thread embedding acupuncture therapy group will receive treatment that consists of 18 sham thread embedding acupuncture sessions over a 24-week period after baseline (once a week for the first 12 weeks and every two weeks for the next 12 weeks).
干预措施: Sham thread embedding acupuncture (Other)
结局指标
主要结局
Relative change in body weight
时间窗: From baseline (week 0) to end of treatment (week 24)
Measured in percentage (%)
次要结局
- Body weight reduction greater than or equal to 5%(From baseline (week 0) to end of treatment (week 24))
- Body weight reduction greater than or equal to 10%(From baseline (week 0) to end of treatment (week 24))
- Change in body weight(From baseline (week 0) to end of treatment (week 24))
- Change in Body Mass Index (BMI)(From baseline (week 0) to end of treatment (week 24))
- Change in body fat rate(From baseline (week 0) to end of treatment (week 24))
- Change in waist circumference(From baseline (week 0) to end of treatment (week 24))
- Change in waist-to-hip ratio(From baseline (week 0) to end of treatment (week 24))
- Change in Systolic Blood Pressure (SBP)(From baseline (week 0) to end of treatment (week 24))
- Change in Diastolic Blood Pressure (DBP)(From baseline (week 0) to end of treatment (week 24))
- Change in Glycated Haemoglobin (HbA1c)(From baseline (week 0) to end of treatment (week 24))
- Change in Fasting Plasma Glucose (FPG)(From baseline (week 0) to end of treatment (week 24))
- Change in fasting serum insulin(From baseline (week 0) to end of treatment (week 24))
- Change in high-density lipoprotein (HDL) cholesterol(From baseline (week 0) to end of treatment (week 24))
- Change in low-density lipoprotein (LDL) cholesterol(From baseline (week 0) to end of treatment (week 24))
- Change in triglycerides(From baseline (week 0) to end of treatment (week 24))
- Change in total cholesterol(From baseline (week 0) to end of treatment (week 24))
- Change in Short Form-36 (SF- 36) Physical Functioning score(From baseline (week 0) to end of treatment (week 24))
- Change in SF-36: Physical Component Summary Score(From baseline (week 0) to end of treatment (week 24))
- Change in SF-36: Mental Component Summary score(From baseline (week 0) to end of treatment (week 24))
研究者
Li bin
Professor
Beijing Hospital of Traditional Chinese Medicine