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

NCT00484705 | Completed DMC

• 6 other identifiers: VGFOUREG-7861K2005-72VP-15445-01AK2005-72VX-15276-01AKLUA/ALF7092DIA2006-001Novo Nordisk Foundation
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Polycystic Ovary Syndrome

Keywords

Androgens; Menstrual pattern; Insulin resistance; Adipocytes; Obesity; Stress; Muscle sympathetic nerve activity; Psychological distress and quality of life

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Low-frequency electro-acupuncture

EXPERIMENTAL

Procedure: Electroacupuncture

Physical exercise

EXPERIMENTAL

Procedure: Physical exercise

Untreated control

ACTIVE COMPARATOR

Procedure: Untreated control

Interventions

Electroacupuncture PROCEDURE

Low-frequency electro-acupuncture

Physical exercise PROCEDURE

Physical exercise

Untreated control PROCEDURE

Untreated control

Eligibility Criteria

• Age: 18 Years - 37 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Göteborg University: lead

Study Sites (1)

Institute of Neuroscience and Physiology, Sahlgrenska Academy, Göteborg University

Gothenburg, 405 30 Göteobrg, Sweden

Location

Related Publications (8)

• 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.

  PMID: 24661732 DERIVED

• 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.

  PMID: 23926234 DERIVED

• 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.

  PMID: 23763822 DERIVED

• 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.

  PMID: 22471422 DERIVED

• 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.

  PMID: 22154367 DERIVED

• 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.

  PMID: 21252248 DERIVED

• 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.

  PMID: 21084397 DERIVED

• 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.

  PMID: 20943753 DERIVED

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Insulin Resistance; Obesity

Interventions

Electroacupuncture; Exercise

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Elisabet Stener-Victorin, Prof, PhD

  Sahlgrenska Academy, Göteborg University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 8, 2007
• First Posted: June 11, 2007
• Study Start: October 1, 2005
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: November 10, 2009

Record last verified: 2009-11

Locations

SE (1)