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

Phase 1

Completed

• Conditions: Polycystic Ovary Syndrome; Insulin Resistance

• Registration Number: NCT01457209
• Lead Sponsor: Göteborg University

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.

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 Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-10-06
• Study First Submitted QC: 2011-10-20
• Study First Posted: 2011-10-21
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-20
• Last Update Posted: 2014-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 42

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in insulin sensitivity	Day 1 and Week 5	glucose disposal rate measured by euglycemic hyperinsulinemic clamp.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Institute of Neuroscienncec and Physiology; 🇸🇪 Göteborg, Sweden