Effect of Acupuncture on Insulin Sensitivity in Women With and Without Polycystic Ovary Syndrome
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Change in insulin sensitivity
研究概览
简要总结
The central hypothesis is that acupuncture break the vicious circle of androgen excess and reverse insulin resistance and improve health related quality of life and affective symptoms in overweight and obese women with and without Polycystic Ovary Syndrome.
详细描述
Polycystic ovary syndrome (PCOS) is the most common endocrine and metabolic disorder in women. The main metabolic phenotype is hyperinsulinemia and insulin resistance, which are independent of body weight and worsen hyperandrogenism and ovulatory dysfunction. Pharmacological treatments are symptom oriented and usually effective but have metabolic and gastrointestinal side effects. Therefore, it is important to evaluate new nonpharmacological treatment strategies, as most women with PCOS require long-term treatment.
Hypothesis and Aims Our central hypothesis is that acupuncture break the vicious circle of androgen excess and reverse insulin resistance and improve health related quality of life and affective symptoms in overweight and obese women with and without PCOS.
The specific aim are designed to test the hypotheses that
- Acupuncture (acute and chronic i.e. 5 weeks treatment, 3 times per week) improves insulin sensitivity in overweight and obese women with and without PCOS
- Acupuncture (acute and chronic i.e. 5 weeks treatment, 3 times per week) regulate key signaling molecules and mitochondrial oxidation/biogenesis in skeletal muscle and adipose tissue in overweight and obese women with and without PCOS
- Acupuncture (chronic i.e. 5 weeks treatment, 3 times per week) improve health related quality of life and symptoms of anxiety and depression in overweight and obese women with and without PCOS
Time frame of the study is 5-6 weeks. No long term follow up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •BMI > 25 to < 35 and
- •Clinical signs of hyperandrogenism (hirsutism or acne) and
- •At least one of the following two signs; oligo/amenorrhea and/or ultrasound-verified polycystic ovaries
- •Controls should have BMI > 25 to < 35, regular cycles with 28 days ± 2 days, no signs of hyperandrogenism.
排除标准
- •Exclusion criteria for all women
- •Age > 38 years
- •Exclusion of other endocrine disorders such as hyperprolactinemia (s-prolactin < 27µg/L), nonclassic congenital adrenal hyperplasia (17-hydroxyprogesterone < 3nmol/L), and androgen secreting tumors.
- •Autoimmune disorders, cancer, Type I diabetes and Type 2 diabetes.
- •Pharmacological treatment (cortisone, antidepressant, antidiabetic, hormonal contraceptives, hormonal ovulation induction or other drugs judged by discretion of investigator) within 12 wks accounts for all participants.
- •Blood pressure >160 / 100 mmHg
- •Pregnancy or breastfeeding the last 6 months
- •Acupuncture last 2 months
- •Language barrier or disabled person with reduced ability to understand information.
结局指标
主要结局
Change in insulin sensitivity
时间窗: Day 1 and Week 5
glucose disposal rate measured by euglycemic hyperinsulinemic clamp.
次要结局
- Change in symptoms of anxiety and depression(Day 1 and Week 5)
- Change in circulating sex steroids, adipokines, lipids and inflammatory markers(Day 1 and Week 5)
- Change in insulin signaling (muscle and adipose tissue)(Day 1 and Week 5)
- Change in health related quality of life(Day 1 and Week 5)