Clinical trial NCT00484705: Polycystic Ovary Syndrome (PCOS) - Effect Of Physical Exercise And Electroacupuncture
Official title: Polycystic Ovary Syndrome (PCOS) - The Female Metabolic Syndrome Genes And Processes In The Aetiology And Pathogenesis Of PCOS And Identification Of New Treatment Strategies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polycystic Ovary Syndrome
Keywords: Androgens
Menstrual pattern
Insulin resistance
Adipocytes
Obesity
Stress
Muscle sympathetic nerve activity
Psychological distress and quality of life
Lead sponsor: Göteborg University
Sponsor class: OTHER
First posted: 2007-06-11
Enrollment: 84
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 37
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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:

  1. Anovulation/oligoovulation defined as ≥ 35 days during the last year
  2. 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

Primary outcomes:
measure: 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.
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Göteborg
country: Sweden
facility: Institute of Neuroscience and Physiology, Sahlgrenska Academy, Göteborg University
Study officials:
affiliation: Sahlgrenska Academy, Göteborg University
name: Elisabet Stener-Victorin, Prof, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.