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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Polycystic Ovary Syndrome, Insulin Resistance

Intervention / Treatment
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* Other: Acupuncture


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 38 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in insulin sensitivity | glucose disposal rate measured by euglycemic hyperinsulinemic clamp. | Day 1 and Week 5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in insulin signaling (muscle and adipose tissue) | Western blot, RT-PCR | Day 1 and Week 5 | 
| Change in health related quality of life | PCOSQ, SF36 | Day 1 and Week 5 | 
| Change in symptoms of anxiety and depression | CPRS-SA | Day 1 and Week 5 | 
| Change in circulating sex steroids, adipokines, lipids and inflammatory markers | Mass spectrometry, ELISA | Day 1 and Week 5 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PCOS, Insulin resistance, Acupuncture