Effects of Myo-inositol in Women With Polycystic Ovary Syndrome

NCT04892186 | Completed

• 1 other identifier: CAAE: 23458719.6.0000.0068
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Polycystic Ovary Syndrome; Resistance, Insulin; Glucose Intolerance

Keywords

myo-inositol; metformin; polycystic ovary syndrome; resistance insulin; glucose intolerance

Outcome Measures

Primary Outcomes (8)

• Menstrual cycle

  Analysis of period calendar.

  6 months

• Change in glucose metabolism

  Glucose tolerance curve with insulin curve will be performed every 3 months.

  Every 3 months for up to 6 months

• Change in glycated hemoglobin

  Glycated hemoglobin will be performed every 3 months.

  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.

  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)

  6 months

• Change in body mass index

  Body mass index (kg/m2) will be assessed every 3 months.

  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.

  Every 3 months for up to 6 months

• Change in body weight in kilograms

  Patients will be weighed every 3 months (measured in kilograms).

  Every 3 months for up to 6 months

Secondary Outcomes (10)

• Assess adherence to treatment.

  Every 3 months for up to 6 months

• Side effects

  Every 3 months for up to 6 months

• Hepatic steatosis

  6 months

• Liver enzymes

  6 months

• Chronic inflammatory process

  6 months

Study Arms (2)

Myo-inositol

EXPERIMENTAL

30 women with resistance insulin or glucose intolerance will receive myo-inositol 2g + folic acid 200mcg, orally, twice a day for 6 months.

Drug: Myo-inositol

Metformin

ACTIVE COMPARATOR

30 women with resistance insulin or glucose intolerance will receive metformin 850 mg, orally, twice a day for 6 months

Drug: Metformin

Interventions

Myo-inositol DRUG

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.

Myo-inositol

Metformin DRUG

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.

Metformin

Eligibility Criteria

• Age: 19 Years - 36 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women aged 19 to 36 with diagnosis of PCOS and insulin resistance or glucose intolerance.

You may not qualify if:

• Previous use of any hormonal treatment in the past three months;
• Other causes of anovulation;
• Gynecological or other associated conditions (endometriosis, adenomyosis or diabetes mellitus);
• FSH (Follicle Stimulating Hormone) \> 15 Ul / L (2nd to 5th day of the cycle);
• Beta-hcG (human chorionic gonadotropin) positive (pregnancy).

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (2)

Hospital Das Clinicas - Fmusp

São Paulo, 05403000, Brazil

Location

Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo

São Paulo, 05403000, Brazil

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Insulin Resistance; Glucose Intolerance

Interventions

Inositol; Metformin

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperglycemia

Intervention Hierarchy (Ancestors)

Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates; Biguanides; Guanidines; Amidines

Study Officials

• Edmund Chada Baracat, Phd

  research coordinator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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, orally, three times a day; Group II (experiment) - they will receive myo-inositol 2g, orally, twice a day.

Study Record Dates

• First Submitted: March 8, 2021
• First Posted: May 19, 2021
• Study Start: March 26, 2021
• Primary Completion: October 20, 2023
• Study Completion: October 20, 2023
• Last Updated: February 20, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)