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The effect of acupuncture or metformin for improvement of insulin sensitivity in women with Polycystic Ovary Syndrome
EU CTIS ID: 2024-514505-64-01
What this study is testing
Primary objective To determine the clinical effectiveness of 4 months of 1) acupuncture + lifestyle management and 2) metformin + lifestyle management compared with 3) lifestyle management only for improvement of insulin sensitivity as measured by HOMA-IR, by the insulin response to glucose assessed by calculating the area under the curve (AUCinsulin) during the oral glucose tolerance test (OGTT), and by glucose regulation (assessed by analyzing Hba1c levels).
- Phase III and phase IV (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Inclusion criteria – women with PCOS 1. Age 18 to 40 years 2. BMI ≥25 to ≤45 (≥23 to ≤37.5 Chinese) given that 95% of all women with PCOS with a BMI 25 are insulin resistant (27, 28). 3. PCOS diagnosis according to Rotterdam criteria 2003 with at least two of the following three symptoms (29): 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 Chinese) (30, 31). 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. 4. Willing to sign the consent form. Inclusion criteria – controls Controls should have BMI >25 to <45, regular cycles with 28 days ± 2 days, no signs of hyperandrogenism. They are excluded if they have menstrual irregularities, signs of hyperandrogenism (FG >4), evidence of PCO morphology on ultrasound.
You likely can't join if
- Exclusion criteria for all women 1. Age >40 2. Exclusion of other endocrine disorders such as non-classic congenital adrenal hyperplasia (17-hydroxyprogesterone < 3nmol/L), androgen secreting tumors or suspected Cushing’s syndrome. 3. Having known kidney disease, autoimmune disorders or cancer. 4. Type I diabetes. 5. 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. 6. Blood pressure >160 / 100 mmHg 7. Pregnancy or breastfeeding the last 6 months 8. Acupuncture last 2 months 9. Daily smoking and alcoholic intake 10. Language barrier or disabled person with reduced ability to understand information.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.