Status:
COMPLETED
Acupuncture to Treat Insulin Resistance in Women With and Without Polycystic Ovary Syndrome
Lead Sponsor:
Göteborg University
Conditions:
Polycystic Ovary Syndrome
Insulin Resistance
Eligibility:
FEMALE
18-38 years
Phase:
PHASE1
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 an...
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 we...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT01457209
Start Date
October 1 2011
End Date
December 1 2013
Last Update
January 22 2014
Active Locations (1)
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1
Institute of Neuroscienncec and Physiology
Gothenburg, Sweden, 43252