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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00484705
First Posted: June 11, 2007
Last Update Posted: November 10, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Göteborg University
  Purpose

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.


Condition Intervention
Polycystic Ovary Syndrome Procedure: Electroacupuncture Procedure: Physical exercise Procedure: Untreated control

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Göteborg University:

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. [ Time Frame: One year ]

Enrollment: 84
Study Start Date: October 2005
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low-frequency electro-acupuncture Procedure: Electroacupuncture
Experimental: Physical exercise Procedure: Physical exercise
Active Comparator: Untreated control Procedure: Untreated control

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 37 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00484705


Locations
Sweden
Institute of Neuroscience and Physiology, Sahlgrenska Academy, Göteborg University
Göteborg, Sweden, 405 30 Göteobrg
Sponsors and Collaborators
Göteborg University
Investigators
Principal Investigator: Elisabet Stener-Victorin, Prof, PhD Sahlgrenska Academy, Göteborg University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00484705     History of Changes
Other Study ID Numbers: VGFOUREG-7861
K2005-72VP-15445-01A
K2005-72VX-15276-01AK
LUA/ALF7092
DIA2006-001
Novo Nordisk Foundation
First Submitted: June 8, 2007
First Posted: June 11, 2007
Last Update Posted: November 10, 2009
Last Verified: November 2009

Keywords provided by Göteborg University:
Androgens
Menstrual pattern
Insulin resistance
Adipocytes
Obesity
Stress
Muscle sympathetic nerve activity
Psychological distress and quality of life

Additional relevant MeSH terms:
Syndrome
Polycystic Ovary Syndrome
Disease
Pathologic Processes
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases