Acupuncture to Treat Insulin Resistance in Women With and Without Polycystic Ovary Syndrome (PCOS-AcupIR)
|ClinicalTrials.gov Identifier: NCT01457209|
Recruitment Status : Completed
First Posted : October 21, 2011
Last Update Posted : January 22, 2014
|Condition or disease||Intervention/treatment||Phase|
|Polycystic Ovary Syndrome Insulin Resistance||Other: Acupuncture||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of Acupuncture on Insulin Sensitivity in Women With and Without Polycystic Ovary Syndrome|
|Study Start Date :||October 2011|
|Primary Completion Date :||December 2013|
|Study Completion Date :||December 2013|
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.
- Change in insulin sensitivity [ Time Frame: Day 1 and Week 5 ]glucose disposal rate measured by euglycemic hyperinsulinemic clamp.
- Change in insulin signaling (muscle and adipose tissue) [ Time Frame: Day 1 and Week 5 ]Western blot, RT-PCR
- Change in health related quality of life [ Time Frame: Day 1 and Week 5 ]PCOSQ, SF36
- Change in symptoms of anxiety and depression [ Time Frame: Day 1 and Week 5 ]CPRS-SA
- Change in circulating sex steroids, adipokines, lipids and inflammatory markers [ Time Frame: Day 1 and Week 5 ]Mass spectrometry, ELISA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01457209
|Institute of Neuroscienncec and Physiology|
|Göteborg, Sweden, 43252|