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

This study has been completed.
Sponsor:
Information provided by:
Göteborg University
ClinicalTrials.gov Identifier:
NCT00484705
First received: June 8, 2007
Last updated: November 9, 2009
Last verified: November 2009
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind
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

Ages Eligible for Study:   18 Years to 37 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Göteborg University

Additional 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
Study First Received: June 8, 2007
Last Updated: November 9, 2009
Health Authority: Sweden: The National Board of Health and Welfare
Sweden: Swedish National Council on Medical Ethics

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:
Polycystic Ovary Syndrome
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 27, 2014