NCT03546595Unknown不适用
Effect of Auricular Points Acupressure for Overweight/Obese Women With Polycystic Ovary Syndrome.
Heilongjiang University of Chinese Medicine1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Homeostasis model assessment-insulin resistance (HOMA-IR)
研究概览
简要总结
The present trial is a pilot study to investigate the effect of auricular acupressure on insulin resistance in women with PCOS.A total of 100 subjects will be enrolled into this study and will be randomized into two groups.
Auricular acupressure or sham auricular acupressure will be treated for three months. The primary outcome is the whole body insulin action assessed with HOMA-IR.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 40 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged between 15 and 40 years.
- •Diagnosis of PCOS according to the modified Rotterdam criteria.
- •2 years after menarche.
- •Body mass index (BMI) equal to or greater than 23 kg/m
- •IR is defined by the homeostaticmodel assessment (HOMA-IR: (fasting insulin (μU/mL)×fasting glucose (mmol/L))/22.5). A value ≥2.14 will be considered to be indicative of IR.
- •With no desire of children within 3 months.
排除标准
- •Administration of other medications known to affect reproductive function or metabolism within the past three months, including oral contraceptives, Gonadotropin-releasing hormone (GnRH) agonists and antagonists, anti androgens, gonadotropins, anti-obesity drugs, Chinese herbal medicines, anti diabetic drugs such as metformin and thiazolidinediones, somatostatin, diazoxide, and calcium channel blockers.
- •Patients with other endocrine disorders including 21-hydroxylase deficiency, hyperprolactinemia, uncorrected thyroid disease, suspected Cushing's syndrome.
- •Patients with known severe organ dysfunction or mental illness.
结局指标
主要结局
Homeostasis model assessment-insulin resistance (HOMA-IR)
时间窗: 3 month
HOMA-IR was calculated as \[Plasma glucose (GLU,mmol/L)\* serum insulin (mIU/L)\] / 22.5.
次要结局
- Androstadienedione (AND)(3 month)
- Sex hormone-binding globulin (SHBG)(3 month)
- Estradiol (E2)(3 month)
- Waist/hip circumference(3 month)
- Acne(3 month)
- The Chinese Quality of Life questionnaire (ChQoL)(3 month)
- Testosterone(T)(3 month)
- Dehydroepiandrosterone sulfate (DHEAS)(3 month)
- Luteinizing hormone (LH)(3 month)
- Weight(3 month)
- Follicle stimulating hormone (FSH)(3 month)
- BMI(3 month)
- FG score(3 month)
- Short-Form Health Survey (SF-36)(3 month)
- Health-related quality of life questionnaire for polycystic ovary syndrome (PCOSQ)(3 month)
研究者
Yan Li
Associate chief physician
Heilongjiang University of Chinese Medicine
研究点 (1)
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