The effect of acupuncture or metformin for improvement of insulin sensitivity in women with Polycystic Ovary Syndrome

Not yet recruiting

• Conditions: Polycystic ovary syndrome

• Registration Number: 2024-514505-64-01
• Lead Sponsor: Karolinska Institutet

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-10-17
• Last Update Posted: 2024-10-17

Recruitment & Eligibility

• Status: Authorised, recruitment pending
• Sex: Female
• Target Recruitment: 353

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in insulin sensitivity after 16 weeks of intervention 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).		Changes in insulin sensitivity after 16 weeks of intervention 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).

Secondary Outcome Measures

Name	Time	Method
After 4 months of intervention: • Changes in secondary metabolic measures, including fasting insulin, c-peptide, glucose, and adipokines, calculation of HOMA-B (i.e. the Islet β-cell function) and the c-peptide index, assessment of the adipokines and lipid profile, body size and proportions and body fat distribution. • Changes in gene expression and DNA methylation profiles related to insulin sensitivity in fat, muscle and endometrial tissue biopsies, and biomarkers in whole blood. • Changes in		After 4 months of intervention: • Changes in secondary metabolic measures, including fasting insulin, c-peptide, glucose, and adipokines, calculation of HOMA-B (i.e. the Islet β-cell function) and the c-peptide index, assessment of the adipokines and lipid profile, body size and proportions and body fat distribution. • Changes in gene expression and DNA methylation profiles related to insulin sensitivity in fat, muscle and endometrial tissue biopsies, and biomarkers in whole blood. • Changes in

Trial Locations

Locations (1)

Karolinska University Hospital; 🇸🇪 Solna, Sweden

Karolinska University Hospital

🇸🇪Solna, Sweden

Elisabet Stener-Victorin

Site contact

+46705643655

elisabet.stener-victorin@ki.se