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

Göteborg University

Status: Completed

Conditions: Polycystic Ovary Syndrome

Treatments: Procedure: Untreated control; Procedure: Electroacupuncture; Procedure: Physical exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT00484705

LUA/ALF7092

Novo Nordisk Foundation

K2005-72VX-15276-01AK

K2005-72VP-15445-01A

DIA2006-001

VGFOUREG-7861

Details and patient eligibility

About

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.

Full 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.

Enrollment: 84 patients

Sex: Female

Ages: 18 to 37 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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84 participants in 3 patient groups

Low-frequency electro-acupuncture

Experimental group

Treatment:

Procedure: Electroacupuncture

Physical exercise

Experimental group

Treatment:

Procedure: Physical exercise

Untreated control

Active Comparator group

Treatment:

Procedure: Untreated control