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

Polycystic Ovary Syndrome Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00484705
• Other study ID #: VGFOUREG-7861
• Secondary ID: K2005-72VP-15445
• Status: Completed
• Phase: N/A
• First received: June 8, 2007
• Last updated: November 9, 2009
• Start date: October 2005
• Est. completion date: October 2008

Study information

• Verified date: November 2009
• Source: Göteborg University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: The National Board of Health and WelfareSweden: Swedish National Council on Medical Ethics
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 37 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Intervention

Procedure:
• Electroacupuncture

• Physical exercise

• Untreated control

Locations

Country	Name	City	State
Sweden	Institute of Neuroscience and Physiology, Sahlgrenska Academy, Göteborg University	Göteborg

Sponsors (1)

Lead Sponsor	Collaborator
Göteborg University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		One year