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Polycystic Ovary Syndrome (PCOS) - Effect Of Physical Exercise And Electroacupuncture (PCOSNTS)

Primary Purpose

Polycystic Ovary Syndrome

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Electroacupuncture
Physical exercise
Untreated control
Sponsored by
Göteborg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring Androgens, Menstrual pattern, Insulin resistance, Adipocytes, Obesity, Stress, Muscle sympathetic nerve activity, Psychological distress and quality of life

Eligibility Criteria

18 Years - 37 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Institute of Neuroscience and Physiology, Sahlgrenska Academy, Göteborg University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Low-frequency electro-acupuncture

Physical exercise

Untreated control

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
June 8, 2007
Last Updated
November 9, 2009
Sponsor
Göteborg University
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1. Study Identification

Unique Protocol Identification Number
NCT00484705
Brief Title
Polycystic Ovary Syndrome (PCOS) - Effect Of Physical Exercise And Electroacupuncture
Acronym
PCOSNTS
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

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Göteborg University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome
Keywords
Androgens, Menstrual pattern, Insulin resistance, Adipocytes, Obesity, Stress, Muscle sympathetic nerve activity, Psychological distress and quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Single
Allocation
Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low-frequency electro-acupuncture
Arm Type
Experimental
Arm Title
Physical exercise
Arm Type
Experimental
Arm Title
Untreated control
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Electroacupuncture
Intervention Type
Procedure
Intervention Name(s)
Physical exercise
Intervention Type
Procedure
Intervention Name(s)
Untreated control
Primary Outcome Measure Information:
Title
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.
Time Frame
One year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
37 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elisabet Stener-Victorin, Prof, PhD
Organizational Affiliation
Sahlgrenska Academy, Göteborg University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Neuroscience and Physiology, Sahlgrenska Academy, Göteborg University
City
Göteborg
ZIP/Postal Code
405 30 Göteobrg
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
24661732
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.
Results Reference
derived
PubMed Identifier
23926234
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.
Results Reference
derived
PubMed Identifier
23763822
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.
Results Reference
derived
PubMed Identifier
22471422
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.
Results Reference
derived
PubMed Identifier
22154367
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.
Results Reference
derived
PubMed Identifier
21252248
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.
Results Reference
derived
PubMed Identifier
21084397
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.
Results Reference
derived
PubMed Identifier
20943753
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.
Results Reference
derived

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Polycystic Ovary Syndrome (PCOS) - Effect Of Physical Exercise And Electroacupuncture

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