Status:
RECRUITING
Acupuncture or Metformin for Insulin Resistance in Women With PCOS
Lead Sponsor:
Karolinska Institutet
Collaborating Sponsors:
Karolinska University Hospital
Peking University
Conditions:
Polycystic Ovary Syndrome
Insulin Resistance
Eligibility:
FEMALE
18-40 years
Phase:
PHASE2
Brief Summary
The hypothesis is that acupuncture is equally effective as metformin (both treatments combined with lifestyle management) in improving whole body glucose homeostasis in insulin resistant women with po...
Detailed Description
Specific Aims The purpose of the study is to perform a randomized controlled trial of women with PCOS, comparing the effectiveness of lifestyle management alone, and in combination with acupuncture or...
Eligibility Criteria
Inclusion criteria - women with PCOS:
- Age 18 to 40 years
- Body mass index (BMI) ≥25 to ≤40 given that 95% of all women with PCOS with a BMI ≥25 are insulin resistant (71,72).
- PCOS diagnosis according to Rotterdam criteria 2003 (73), with at least two of the following three symptoms: Clinical signs of hyperandrogenism (hirsutism or acne); oligo/amenorrhea; and/or polycystic ovaries (PCOS). Hirsutism is defined as a self-reported Ferriman-Gallwey (FG) score ≥8 (≥5 Asian) (74,75). Acne is defined by a positive response to the question Do you have acne? Oligomenorrhea is defined as an intermenstrual interval >35 days and <8 menstrual bleedings in the past year. Amenorrhea as <3 cycles per year. PCO is defined by transvaginal ultrasound with ≥12 follicles 2-9 mm and/or ovarian volume ≥10 ml in one or both ovaries.
- Willing to sign the consent form.
Inclusion criteria - controls:
Controls should have BMI >25 to <40, regular cycles with 28 days ± 2 days, and no signs of hyperandrogenism. They are excluded if they have menstrual irregularities, signs of hyperandrogenism (FG >4), or evidence of PCO morphology on ultrasound.
Exclusion criteria for all women
- Age >40
- Exclusion of other endocrine disorders such as non-classic congenital adrenal hyperplasia (17-hydroxyprogesterone < 3nmol/L), androgen secreting tumors or suspected Cushing's syndrome.
- Having known renal disease (creatinine clearance < 60 mL/min), hepatic insufficiency, autoimmune disorders or cancer.
- Any acute condition with potential to alter renal function or cause tissue hypoxia.
- Type I diabetes.
- Pharmacological treatment (cortizon, antidepressant, other antidiabetic treatment such as insulin and acarbose, hormonal contraceptives, hormonal ovulation induction or other drugs judged by discretion of investigator) within 12 weeks. Depo Provera or similar within 6 months.
- Hypersensitivity to metformin hydrochloride or to any of the excipients.
- Blood pressure >160 / 100 mmHg
- Pregnancy or breastfeeding the last 6 months
- Acupuncture the last 2 months
- Daily smoking and alcoholic intake
- Language barrier or disabled person with reduced ability to understand the information given.
In total 50 controls will be matched at baseline (age, weight and BMI) to women with PCOS. Controls will undergo screening and baseline visit, but will not be randomized to any treatment.
Key Trial Info
Start Date :
December 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
303 Patients enrolled
Trial Details
Trial ID
NCT02647827
Start Date
December 1 2015
End Date
June 1 2026
Last Update
October 9 2024
Active Locations (2)
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1
Peking University
Beijing, China, 100871
2
Karolinska University Hospital
Stockholm, Sweden, 17176