The study will be carried out at the hospital of the medical school of sao paulo (HC-FMUSP) and the goal is to compare the effects of the administration of myo-inositol in relation to the effects of metformin in women with Polycystic Ovary Syndrome and insulin resistance or glucose intolerance. Menstrual cycle, hyperandrogenism, chronic inflammatory process, carbohydrate metabolism, hepatic steatosis will be evaluated. In total, 60 women in the reproductive period, with a variable age between 18 and 36 years old will be recruited and randomized in two groups: intervention- myo-inositol for 6 months, control group will use metformin also for 6 months.
The study will involve 60 women in the reproductive period, with a variable between 19 and 36 years old and diagnosed with polycystic ovary syndrome (PCOS), according to Rotterdam- European Society of Human Reproduction and Embryology (ESHRE) / American Society for Reproductive Medicine (ASRM) criteria defined in 2003 and revised in 2018, and insulin resistance (presence acanthosis nigricans) or glucose intolerance (fasting glycemia, glycated hemoglobin or 75g glycemic overload and blood glucose assessment after 2 hours). It is a comparative and non-inferiority study of myo-inositol in relation to metformin. They will be divided into two groups of 30 patients: Group I (control) - they will receive metformin 850 mg, orally, twice a day; Group II (experiment) - they will receive myo-inositol 2g + folic acid 200mcg, orally, twice a day.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
30 women with polycystic ovary syndrome and insulin resistance or glucose intolerance will used myo-inositol 2g + folic acid 200mcg twice daily for 6 months, having a re-evaluation every 3 months. Evaluation will be made by transvaginal ultrasound, abdominal ultrasound, inflammatory tests, hormonal tests, glycemic curve with insulin curve, lipid profile, body mass index, evaluation of abdominal and hip circumference.
30 women with polycystic ovary syndrome and insulin resistance or glucose intolerance will used metformin 850 mg twice a day for 6 months, having a re-evaluation every 3 months. Evaluation will be made by transvaginal ultrasound, abdominal ultrasound, inflammatory tests, hormonal tests, glycemic curve with insulin curve, lipid profile, body mass index, evaluation of abdominal and hip circumference.
Hospital Das Clinicas - Fmusp
São Paulo, Brazil
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
São Paulo, Brazil
Menstrual cycle
Analysis of period calendar.
Time frame: 6 months
Change in glucose metabolism
Glucose tolerance curve with insulin curve will be performed every 3 months.
Time frame: Every 3 months for up to 6 months
Change in glycated hemoglobin
Glycated hemoglobin will be performed every 3 months.
Time frame: Every 3 months for up to 6 months
Change in ultrasound of the ovaries
Transvaginal ultrasound to assess ovarian volume (measured in cubic centimeters) will be done before and after treatment.
Time frame: 6 months
Change in antral follicle count
Ultrasound of the ovaries will be done before and after treatment for antral follicle count (all follicles from 2 to 9 mm will be measured)
Time frame: 6 months
Change in body mass index
Body mass index (kg/m2) will be assessed every 3 months.
Time frame: Every 3 months for up to 6 months
Change in Abdominal Circumference and Hip Circumference
Abdominal circumference and hip circumference (measured in centimeters) will be assessed every 3 months.
Time frame: Every 3 months for up to 6 months
Change in body weight in kilograms
Patients will be weighed every 3 months (measured in kilograms).
Time frame: Every 3 months for up to 6 months
Assess adherence to treatment.
Medication use diary will be delivered and will be reviewed every 3 months to assess adherence to treatment (good adherence will be considered use of more than 80% of the medication provided).
Time frame: Every 3 months for up to 6 months
Side effects
Questionnaire will be carried out every 3 months for patient to describe the 3 main side effects and how much they have hindered the treatment or not.
Time frame: Every 3 months for up to 6 months
Hepatic steatosis
Initial liver ultrasound will be done and repeated after 6 months of treatment to assess the presence or absence of hepatic steatosis and classify it as mild (grade 1), moderate (grade 2) and severe (grade 3).
Time frame: 6 months
Liver enzymes
Liver enzymes (aspartate aminotransferase, alanine aminotransferase,alkaline phosphatase) will be collected before and after treatment
Time frame: 6 months
Chronic inflammatory process
Chronic inflammatory markers will be accessed by analyzing RNA messenger from cervical-vaginal cytology before and after treatment.
Time frame: 6 months
C-reactive protein
Chronic inflammatory process will be also evaluated by serum measurement of c-reactive protein before and after treatment.
Time frame: 6 months
Homocysteine
Serum homocysteine dosage will be done before and after treatment to help assess a chronic inflammatory process.
Time frame: 6 months
Change in Lipid Profile
Serum dosage of the lipid profile (high density lipoprotein - HDL, low density lipoprotein - LDL , very low density lipoprotein - VLDL, triglycerides, total cholesterol) will be done every 3 months
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Time frame: Every 3 months for up to 6 months
Modified Ferriman-Gallwey Score
Modified Ferriman-Gallwey Score will be performed before and after treatment and patients with a score above 7 will be considered hirsute.
Time frame: 6 months
Hormonal dosage (FSH, LH, progesterone, estradiol)
Hormonal dosage (FSH - Follicle-stimulating hormone, LH - luteinizing hormone, progesterone, estradiol) will be preformed before and after treatment.
Time frame: 6 months