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

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ClinicalTrials.gov Identifier: NCT01457209
Recruitment Status : Completed
First Posted : October 21, 2011
Last Update Posted : January 22, 2014
Sponsor:
Information provided by (Responsible Party):
Göteborg University

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Insulin Resistance Other: Acupuncture Phase 1

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Acupuncture on Insulin Sensitivity in Women With and Without Polycystic Ovary Syndrome
Study Start Date : October 2011
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Insulin
U.S. FDA Resources

Arms and Interventions
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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.


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


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

  2. Change in health related quality of life [ Time Frame: Day 1 and Week 5 ]
    PCOSQ, SF36

  3. Change in symptoms of anxiety and depression [ Time Frame: Day 1 and Week 5 ]
    CPRS-SA

  4. Change in circulating sex steroids, adipokines, lipids and inflammatory markers [ Time Frame: Day 1 and Week 5 ]
    Mass spectrometry, ELISA


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 38 Years   (Adult)
Sexes 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01457209


Locations
Sweden
Institute of Neuroscienncec and Physiology
Göteborg, Sweden, 43252
Sponsors and Collaborators
Göteborg University
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Göteborg University
ClinicalTrials.gov Identifier: NCT01457209     History of Changes
Other Study ID Numbers: PCOS-AcupIR
First Posted: October 21, 2011    Key Record Dates
Last Update Posted: January 22, 2014
Last Verified: January 2014

Keywords provided by Göteborg University:
PCOS
Insulin resistance
Acupuncture

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Syndrome
Insulin Resistance
Disease
Pathologic Processes
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