METFORMIN HYDROCHLORIDE for Polycystic ovary syndrome

Inclusion criteria

• {"criterion_text":"- Inclusion criteria – women with PCOS 1. Age 18 to 40 years\n- 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).\n- 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.\n- 4. Willing to sign the consent form.\n- Inclusion criteria – controls Controls should have BMI >25 to <45, regular cycles with 28 days ± 2 days, no signs of hyperandrogenism."}

Exclusion criteria

• {"criterion_text":"- Exclusion criteria for all women 1. Age >40\n- 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.\n- 3. Having known kidney disease, autoimmune disorders or cancer.\n- 4. Type I diabetes.\n- 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.\n- 6. Blood pressure >160 / 100 mmHg\n- 7. Pregnancy or breastfeeding the last 6 months\n- 8. Acupuncture last 2 months\n- 9. Daily smoking and alcoholic intake\n- 10. Language barrier or disabled person with reduced ability to understand information."}

Primary endpoints

• {"endpoint_text":"- 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).","definition_or_measurement_approach":"Measured after 16 weeks. Insulin sensitivity assessed by HOMA-IR; insulin response to glucose assessed by calculating AUCinsulin during an OGTT; glucose regulation assessed by HbA1c analysis."}

Secondary endpoints

• {"endpoint_text":"- 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","definition_or_measurement_approach":"Assessed after 4 months of intervention. Includes fasting insulin, c-peptide, glucose, adipokines, HOMA-B and c-peptide index, lipid profile, anthropometric measures and body fat distribution; gene expression and DNA methylation profiles in fat, muscle and endometrial biopsies; biomarkers in whole blood. (Endpoint text truncated in source.)"}

Sweden

Earliest CTIS Part Ii Submission Date

15-10-2024

Latest Decision Or Authorization Date

17-10-2024

Processing Time Days

2

Number Of Sites

1

Number Of Participants

353

Primary sponsor

Full Name

Karolinska Institutet

Organisation Type

Educational Institution

Country Of Registered Address

Sweden