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Completed

NCT Number: NCT01457209

Acupuncture to Treat Insulin Resistance in Women With and Without Polycystic Ovary Syndrome

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.

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Key information

About this study

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

  • 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
  • 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
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • Age > 38 years
  • Exclusion of other endocrine disorders such as hyperprolactinemia (s-prolactin < 27µg/L), nonclassic congenital adrenal hyperplasia (17-hydroxyprogesterone < 3nmol/L), and androgen secreting tumors.
  • Autoimmune disorders, cancer, Type I diabetes and Type 2 diabetes.
  • 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.
  • Blood pressure >160 / 100 mmHg
  • Pregnancy or breastfeeding the last 6 months
  • Acupuncture last 2 months
  • Language barrier or disabled person with reduced ability to understand information.

Treatment and study plan

Acupuncture

Other

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.

Primary outcomes

  1. Change in insulin sensitivity

    Time frame: Day 1 and Week 5

    glucose disposal rate measured by euglycemic hyperinsulinemic clamp.

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Göteborg University

Other

Registry information

Official study title

Effect of Acupuncture on Insulin Sensitivity in Women With and Without Polycystic Ovary Syndrome

Acronym: PCOS-AcupIR

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Oct 21, 2011
Registry last updated
Jan 22, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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