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临床试验/NCT06609200
NCT06609200尚未招募不适用

Electro-acupuncture for the Obese Patient with Insulin Resistance: a Randomized Sham-controlled Clinical Trial

Nanyang Technological University0 个研究点目标入组 60 人开始时间: 2024年10月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
主要终点
HOMA-IR

研究概览

简要总结

This clinical trial aims to evaluate the efficacy and safety of electro-acupuncture for obese patients with insulin resistance. 60 participants will be randomized and allocated to either the electro-acupuncture arm or the sham acupuncture arm.

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)

盲法说明

After a participant's eligibility is confirmed, a randomization number that corresponds to the group allocation will be provided to the acupuncturist. The clinical assessor and participants will be blinded to the allocation.

入排标准

年龄范围
21 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Men and women aged between 21 and 65 years old
  • •BMI ≥ 25 kg/m2
  • •HOMA-IR ≥ 2.14, (HOMA-IR = fasting insulin (ųU/mL)* fasting glucose (mmol/L)/22.5)
  • •Not receiving any other weight control measures or any medical and/or drug history in the last 3 months

排除标准

  • •Diabetes mellitus
  • •Treating with drugs that may affect insulin sensitivity
  • •Changes 10% of usual body weight in the previous 6 months weight
  • •Endocrine diseases, including thyroid disorder, pituitary disorder, sex gland disorder, etc.
  • •Heart diseases, including arrhythmia, heart failure, and myocardial infarction, participants with pacemakers
  • •Allergy and immunology diseases
  • •Bleeding tendency
  • •Pregnant or lactating women
  • •Impaired hepatic or renal function
  • •Stroke or unable to exercise

研究组 & 干预措施

Electroacupuncture group

Experimental

The WHO Standardized Acupuncture Points Location [2] will be used to identify the location of these acupoints, Tianshu(ST-25), Daheng(SP-15), Daimai(GB-24), Qihai(CV-6), Zhongwan(CV-12), Zusanli (ST-36), Fenlong(ST-40), and Sanyinjiao(SP-6). After sterilizing the skin, sterile adhesive pads will be pasted on acupoints first, and then needles of size 0.30*75 mm will be inserted into the acupoints to a depth of 50 mm outward and upward slightly. Needles will be lifted, thrust, and twirled evenly 3 times to achieve "de-qi". Paired electrodes of the EA apparatus will be attached transversely to the acupoint respectively with a continuous wave of 50 Hz and a current intensity of 1-5 mA (preferably with the skin around the acupoints shivering mildly without pain) for 30 min. Patients will be treated with electroacupuncture 2 sessions per week over 8 consecutive weeks, 16 sessions for each patient.

干预措施: Acupuncture needles (Device)

Sham acupuncture group

Sham Comparator

The sham electro-acupuncture group (SEA) penetrates acupuncture on non-acupuncture points (1 cm away from the acupuncture point and meridian). The same type of acupuncture needles will be used for SEA with the exact skin sterilization method. All acupuncture points will be needled perpendicularly with a guide tube. Insertion depth will be approximately 50 mm, depending on the location of individual points. Each point will be connected to a sham electro-stimulator (showing a continuous wave at a frequency of 30 Hz but without actual stimulation). All needles will be removed after 30 min of needle retention. Patients will be treated with sham electroacupuncture 2 sessions per week over 8 consecutive weeks, 16 sessions for each patient in total.

干预措施: Acupuncture needles (Device)

结局指标

主要结局

HOMA-IR

时间窗: From enrollment to the end of follow up at 16 weeks

HOMA-IR = fasting insulin (ųU/mL)\* fasting glucose (mmol/L)/22.5

次要结局

  • Body Mass Index (BMI)(From enrollment to the end of follow up at 16 weeks)
  • Waist-to-hip ratio(From enrollment to the end of follow up at 16 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Linda Zhong

Assoc prof

Nanyang Technological University

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