Acupuncture to Treat Insulin Resistance in Women With and Without Polycystic Ovary Syndrome (PCOS-AcupIR)
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Purpose
| 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 |
- Change in insulin sensitivity [ Time Frame: Day 1 and Week 5 ] [ Designated as safety issue: Yes ]glucose disposal rate measured by euglycemic hyperinsulinemic clamp.
- 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
| Enrollment: | 42 |
| Study Start Date: | October 2011 |
| Study Completion Date: | December 2013 |
| Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
-
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.
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.
Eligibility| Ages Eligible for Study: | 18 Years to 38 Years (Adult) |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01457209
| Sweden | |
| Institute of Neuroscienncec and Physiology | |
| Göteborg, Sweden, 43252 | |
More Information
| 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: | January 20, 2014 |
| 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 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 |
ClinicalTrials.gov processed this record on September 23, 2016