NCT06609200尚未招募不适用
Electro-acupuncture for the Obese Patient with Insulin Resistance: a Randomized Sham-controlled Clinical Trial
适应症
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; treatment 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.
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
Linda Zhong
Assoc prof
Nanyang Technological University
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