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Acupuncture to Treat Insulin Resistance in Women With and Without Polycystic Ovary Syndrome (PCOS-AcupIR)

This study is currently recruiting participants.
Verified April 2013 by Göteborg University
Sponsor:
Information provided by (Responsible Party):
Göteborg University
ClinicalTrials.gov Identifier:
NCT01457209
First received: October 6, 2011
Last updated: April 5, 2013
Last verified: April 2013
History of Changes
  Purpose

The central hypothesis is that acupuncture break the vicious circle of androgen excess and reverse insulin resistance and improve health related quality of life and affective symptoms in overweight and obese women with and without Polycystic Ovary Syndrome.


Condition Intervention Phase
Polycystic Ovary Syndrome
Insulin Resistance
 Other: Acupuncture
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Acupuncture on Insulin Sensitivity in Women With and Without Polycystic Ovary Syndrome

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Göteborg University:

Primary Outcome Measures:
  • Change in insulin sensitivity [ Time Frame: Day 1 and Week 5 ] [ Designated as safety issue: Yes ]
    glucose disposal rate measured by euglycemic hyperinsulinemic clamp.


Secondary Outcome Measures:
  • Change in insulin signaling (muscle and adipose tissue) [ Time Frame: Day 1 and Week 5 ] [ Designated as safety issue: Yes ]
    Western blot, RT-PCR

  • Change in health related quality of life [ Time Frame: Day 1 and Week 5 ] [ Designated as safety issue: Yes ]
    PCOSQ, SF36

  • Change in symptoms of anxiety and depression [ Time Frame: Day 1 and Week 5 ] [ Designated as safety issue: Yes ]
    CPRS-SA

  • Change in circulating sex steroids, adipokines, lipids and inflammatory markers [ Time Frame: Day 1 and Week 5 ] [ Designated as safety issue: Yes ]
    Mass spectrometry, ELISA


Estimated Enrollment: 40
Study Start Date: October 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Acupuncture

    Needle placement in abdominal muscles, in m. vastus lateralis, lower leg and hands.

    Stimulation: Manual rotation of the needles and electrical stimulation of the needles in the abdominal muscles and m. vastus lateralis will be stimulated electrically with low burst frequency Duration: 30 min Treatment: 3 times/wk during 5 weeks.

Detailed Description:

Polycystic ovary syndrome (PCOS) is the most common endocrine and metabolic disorder in women. The main metabolic phenotype is hyperinsulinemia and insulin resistance, which are independent of body weight and worsen hyperandrogenism and ovulatory dysfunction. Pharmacological treatments are symptom oriented and usually effective but have metabolic and gastrointestinal side effects. Therefore, it is important to evaluate new nonpharmacological treatment strategies, as most women with PCOS require long-term treatment.

Hypothesis and Aims Our central hypothesis is that acupuncture break the vicious circle of androgen excess and reverse insulin resistance and improve health related quality of life and affective symptoms in overweight and obese women with and without PCOS.

The specific aim are designed to test the hypotheses that

  1. Acupuncture (acute and chronic i.e. 5 weeks treatment, 3 times per week) improves insulin sensitivity in overweight and obese women with and without PCOS
  2. Acupuncture (acute and chronic i.e. 5 weeks treatment, 3 times per week) regulate key signaling molecules and mitochondrial oxidation/biogenesis in skeletal muscle and adipose tissue in overweight and obese women with and without PCOS
  3. Acupuncture (chronic i.e. 5 weeks treatment, 3 times per week) improve health related quality of life and symptoms of anxiety and depression in overweight and obese women with and without PCOS

Time frame of the study is 5-6 weeks. No long term follow up.

  Eligibility

Ages Eligible for Study:   18 Years to 38 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • BMI > 25 to < 35 and
  • Clinical signs of hyperandrogenism (hirsutism or acne) and
  • At least one of the following two signs; oligo/amenorrhea and/or ultrasound-verified polycystic ovaries

Controls should have BMI > 25 to < 35, regular cycles with 28 days ± 2 days, no signs of hyperandrogenism.

Exclusion Criteria:

Exclusion criteria for all women

  1. Age > 38 years
  2. Exclusion of other endocrine disorders such as hyperprolactinemia (s-prolactin < 27µg/L), nonclassic congenital adrenal hyperplasia (17-hydroxyprogesterone < 3nmol/L), and androgen secreting tumors.
  3. Autoimmune disorders, cancer, Type I diabetes and Type 2 diabetes.
  4. Pharmacological treatment (cortisone, antidepressant, antidiabetic, hormonal contraceptives, hormonal ovulation induction or other drugs judged by discretion of investigator) within 12 wks accounts for all participants.
  5. Blood pressure >160 / 100 mmHg
  6. Pregnancy or breastfeeding the last 6 months
  7. Acupuncture last 2 months
  8. Language barrier or disabled person with reduced ability to understand information.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01457209

Contacts
Contact: Elisabet Stener-Victorin, PhD +46317863557 elisabet.stener-victorin@neuro.gu.se

Locations
Sweden
Institute of Neuroscienncec and Physiology Recruiting
Göteborg, Sweden, 43252
Contact: Elisabet Stener-Victorin, PhD     +46317863557     elisabet.stener-victorin@neuro.gu.se    
Principal Investigator: Elisabet Stener-Victorin, PhD            
Sponsors and Collaborators
Göteborg University
  More Information

No publications provided

Responsible Party: Göteborg University
ClinicalTrials.gov Identifier: NCT01457209     History of Changes
Other Study ID Numbers: PCOS-AcupIR
Study First Received: October 6, 2011
Last Updated: April 5, 2013
Health Authority: Sweden: Regional Ethical Review Board
Sweden: Swedish Research Council

Keywords provided by Göteborg University:
PCOS
Insulin resistance
Acupuncture

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
 Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013