Effect of Acupuncture on Insulin Sensitivity in Women With Polycystic Ovary Syndrome and Insulin Resistance: Study Protocol of a Prospective Observational Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- HOMA-IR
研究概览
简要总结
Hyperinsulinemia and insulin resistance play a key role in the pathogenesis of polycystic ovary syndrome (PCOS). Insulin resistance is significantly associated with the long-term risks of metabolic syndrome and cardiovascular disease. Acupuncture with electrical stimulation has in rats with dihydrotestosterone (DHT)-induced PCOS been shown to improve insulin sensitivity. Whether these findings can be translated into women with PCOS has not been investigated. Therefore, this study aims to evaluate whether acupuncture improves insulin sensitivity, ovulation rate and quality of life in women with PCOS. Our hypothesis is that acupuncture with combined manual and low-frequency electrical stimulation of the needles improves insulin resistance, induces ovulation and improves quality of life.
详细描述
This is a prospective observational study. A total of 112 women with PCOS and insulin resistance will be recruited and randomized into two groups according to their body mass index (BMI), i.e. normal weight (BMI=18.5-23Kg/m2) group and overweight or obese (BMI > 23Kg/m2) group1. The acupuncture treatment will last for six months, 3 times per week, 30 minutes per treatment. The primary outcome is changes in insulin sensitivity from baseline to after 6 months of acupuncture treatment measured by OGTT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years.
- •BMI ≥18.5Kg/m2
- •Confirmed diagnosis of PCOS according to the Rotterdam criteria: Oligo-, amenorrhea (less than 8 cycles per year) or/clinical or biochemical hyperandrogenism and/or polycystic ovarian morphology.
- •IR defined by the homeostatic model assessment (HOMA-IR: fasting insulin x fasting glucose/22.5) and 2.14 will be used as the cut off
- •No desire of children and using barrier methods of contraception for 1 year.
- •Willing to sign the consent form
排除标准
- •With other endocrine disorders such as hyperprolactinemia (defined as two prolactin levels at least one week apart 25 ng/mL or greater or as determined by local normative values), nonclassic congenital adrenal hyperplasia (17-hydroxyprogesterone <3nmol/L), and androgen secreting tumors.
- •Patients with FSH levels > 15 mIU/mL. A normal level within the last year is adequate for entry.
- •Patients with uncorrected thyroid disease (defined as TSH < 0.2 mIU/mL or >5.5 mIU/mL). A normal level within the last year is adequate for entry.
- •Patients diagnosed with Type I diabetes, or Type I and Type II patients who receiving antidiabetic medications such as insulin, thiazolidinediones, acarbose, or sulfonylureas likely to confound the effects of study medication; patients currently receiving metformin for a diagnosis of Type I or Type II diabetes or for PCOS are also specifically excluded.
- •Patients with suspected Cushing's syndrome.
- •Use of hormonal or other medication including Chinese Herbal prescriptions which may affect the outcome at least in the past 3 months.
- •Pregnancy within the last 6 weeks.
- •Post-abortion or postpartum within last 6 weeks.
- •Breastfeeding within the last 6 months.
- •Patients received Acupuncture treatment related to PCOS within the last 2 months.
- •Patients who have undergone a bariatric surgery procedure in the recent past (<12 months) and are in a period of acute weight loss.
- •Patients with known congenital adrenal hyperplasia.
- •Not willing to give written consent to the study.
结局指标
主要结局
HOMA-IR
时间窗: baseline,treat for 3 and 6 month ,3 or 6 month follow-up
次要结局
- FSH(baseline,up to 6 month,the follow-up of 3 or 6 month)
- LH(baseline,up to 6 month,the follow-up of 3 or 6 month)
- Androgen(baseline,up to 6 month,the follow-up of 3 or 6 month)
- Progesterone(baseline,up to 6 month,the follow-up of 3 or 6 month)
- Prolactin(baseline,up to 6 month,the follow-up of 3 or 6 month)
- dehydroepiandrosterone(sodium)sulfate(baseline,up to 6 month,the follow-up of 3 or 6 month)
- sex hormone binding globulin(baseline,up to 6 month,the follow-up of 3 or 6 month)
- c-peptide(baseline,up to 6 month,the follow-up of 3 or 6 month)
- Apoa1(baseline,up to 6 month,the follow-up of 3 or 6 month)
- Estradiol(baseline,up to 6 month,the follow-up of 3 or 6 month)
- ApoB(baseline,up to 6 month,the follow-up of 3 or 6 month)
- TC(baseline,up to 6 month,the follow-up of 3 or 6 month)
- TG(baseline,up to 6 month,the follow-up of 3 or 6 month)
- glycosylated hemoglobin(baseline,up to 6 month,the follow-up of 3 or 6 month)
- Questionnaire investigation(baseline,up to 6 month,the follow-up of 3 or 6 month)
- Transvaginal ultrasound(baseline,up to 6 month,the follow-up of 3 or 6 month)
研究者
Yanhua-Zheng
Attending physician
The First Affiliated Hospital of Guangzhou Medical University