Polycystic Ovary Syndrome (PCOS) - Effect Of Physical Exercise And Electroacupuncture
NCT ID: NCT00484705
Last Updated: 2009-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
84 participants
INTERVENTIONAL
2005-10-31
2008-10-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
SINGLE
Study Groups
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Low-frequency electro-acupuncture
Electroacupuncture
Physical exercise
Physical exercise
Untreated control
Untreated control
Interventions
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Electroacupuncture
Physical exercise
Untreated control
Eligibility Criteria
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Inclusion Criteria
1. Anovulation/oligoovulation defined as ≥ 35 days during the last year
2. Clinical signs of hyperandrogenism (hirsutism, acne)
Exclusion Criteria
* 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
18 Years
37 Years
FEMALE
Yes
Sponsors
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Göteborg University
OTHER
Principal Investigators
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Elisabet Stener-Victorin, Prof, PhD
Role: PRINCIPAL_INVESTIGATOR
Sahlgrenska Academy, Göteborg University
Locations
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Institute of Neuroscience and Physiology, Sahlgrenska Academy, Göteborg University
Gothenburg, , Sweden
Countries
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References
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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.
Other Identifiers
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K2005-72VP-15445-01A
Identifier Type: -
Identifier Source: secondary_id
K2005-72VX-15276-01AK
Identifier Type: -
Identifier Source: secondary_id
LUA/ALF7092
Identifier Type: -
Identifier Source: secondary_id
DIA2006-001
Identifier Type: -
Identifier Source: secondary_id
Novo Nordisk Foundation
Identifier Type: -
Identifier Source: secondary_id
VGFOUREG-7861
Identifier Type: -
Identifier Source: org_study_id
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