Polycystic Ovary Syndrome (PCOS) - Effect Of Physical Exercise And Electroacupuncture (PCOSNTS)
Polycystic Ovary Syndrome (PCOS) - The Female Metabolic Syndrome Genes And Processes In The Aetiology And Pathogenesis Of PCOS And Identification Of New Treatment Strategies
Hypothesis:
The overall hypothesis is that women with PCOS, both obese and non-obese, have larger adipocytes, altered metabolism and signs of inflammation in adipose tissue and that these changes are associated with high sympathetic nerve activity, hyperandrogenism hyperinsulinaemia, insulin resistance with progression to type II diabetes and cardiovascular disease (CVD) as well as psychological distress and reduced quality of life. Physical exercise and electro-acupuncture decrease high concentrations of androgens, induce regulare menstrual pattern, inhibits high sympathetic activity and restore the PCOS induced disturbances.
研究概览
详细说明
Primary outcome: Changes in androgen concentrations and menstrual pattern
Secondary outcome: changes in sympathetic nerve activity, uterus peristalsis, ovarian morphology, adipose tissue related variables, insulin sensitivity, coagulation factors and health related quality of life and symptoms of anxiety and depression.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Göteborg、瑞典、405 30 Göteobrg
- Institute of Neuroscience and Physiology, Sahlgrenska Academy, Göteborg University
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
To get the diagnosis polycystic ovary syndrome (PCOS), ultrasonography should reveal at least 1 ovary with PCO according to the Rotterdam diagnostic criteria as well as one of the following two symptoms:
- Anovulation/oligoovulation defined as ≥ 35 days during the last year
- Clinical signs of hyperandrogenism (hirsutism, acne)
Exclusion Criteria:
- Cardiovascular disease
- Diabetes mellitus
- Other endocrine disease (congenital adrenal hyperplasia, androgen producing tumour, Cushing's syndrome)
- Estrogen/gestagen treatment during the last 3 months
- Breast-feeding the last 6 months
- Antiandrogen treatment the last 3 months
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:阶乘赋值
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:体育锻炼
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实验性的:低频电针
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有源比较器:Untreated control
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
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To measure if physical exercise and electro-acupuncture restores endocrine, neuroendocrine, metabolic and immunological disturbances related to sympathetic nerve activity as well as psychological distress and improve quality of life in women with PCOS.
大体时间:One year
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One year
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合作者和调查者
调查人员
- 首席研究员:Elisabet Stener-Victorin, Prof, PhD、Sahlgrenska Academy, Göteborg University
出版物和有用的链接
一般刊物
- Leonhardt H, Hellstrom M, Gull B, Lind AK, Nilsson L, Janson PO, Stener-Victorin E. Ovarian morphology assessed by magnetic resonance imaging in women with and without polycystic ovary syndrome and associations with antimullerian hormone, free testosterone, and glucose disposal rate. Fertil Steril. 2014 Jun;101(6):1747-56.e1-3. doi: 10.1016/j.fertnstert.2014.02.022. Epub 2014 Mar 21.
- Leonhardt H, Gull B, Stener-Victorin E, Hellstrom M. Ovarian volume and antral follicle count assessed by MRI and transvaginal ultrasonography: a methodological study. Acta Radiol. 2014 Mar;55(2):248-56. doi: 10.1177/0284185113495835. Epub 2013 Aug 7.
- Stener-Victorin E, Holm G, Janson PO, Gustafson D, Waern M. Acupuncture and physical exercise for affective symptoms and health-related quality of life in polycystic ovary syndrome: secondary analysis from a randomized controlled trial. BMC Complement Altern Med. 2013 Jun 13;13:131. doi: 10.1186/1472-6882-13-131.
- Billhult A, Stener-Victorin E. Acupuncture with manual and low frequency electrical stimulation as experienced by women with polycystic ovary syndrome: a qualitative study. BMC Complement Altern Med. 2012 Apr 3;12:32. doi: 10.1186/1472-6882-12-32.
- Stener-Victorin E, Baghaei F, Holm G, Janson PO, Olivecrona G, Lonn M, Manneras-Holm L. Effects of acupuncture and exercise on insulin sensitivity, adipose tissue characteristics, and markers of coagulation and fibrinolysis in women with polycystic ovary syndrome: secondary analyses of a randomized controlled trial. Fertil Steril. 2012 Feb;97(2):501-8. doi: 10.1016/j.fertnstert.2011.11.010. Epub 2011 Dec 9.
- Manneras-Holm L, Baghaei F, Holm G, Janson PO, Ohlsson C, Lonn M, Stener-Victorin E. Coagulation and fibrinolytic disturbances in women with polycystic ovary syndrome. J Clin Endocrinol Metab. 2011 Apr;96(4):1068-76. doi: 10.1210/jc.2010-2279. Epub 2011 Jan 20.
- Manneras-Holm L, Leonhardt H, Kullberg J, Jennische E, Oden A, Holm G, Hellstrom M, Lonn L, Olivecrona G, Stener-Victorin E, Lonn M. Adipose tissue has aberrant morphology and function in PCOS: enlarged adipocytes and low serum adiponectin, but not circulating sex steroids, are strongly associated with insulin resistance. J Clin Endocrinol Metab. 2011 Feb;96(2):E304-11. doi: 10.1210/jc.2010-1290. Epub 2010 Nov 17.
- Jedel E, Labrie F, Oden A, Holm G, Nilsson L, Janson PO, Lind AK, Ohlsson C, Stener-Victorin E. Impact of electro-acupuncture and physical exercise on hyperandrogenism and oligo/amenorrhea in women with polycystic ovary syndrome: a randomized controlled trial. Am J Physiol Endocrinol Metab. 2011 Jan;300(1):E37-45. doi: 10.1152/ajpendo.00495.2010. Epub 2010 Oct 13.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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