Myo-inositol Versus D-chiro-inositol in the Treatment of Polycystic Ovary Syndrome and Insulin Resistance: Evaluation of Clinical, Metabolic, Endocrine and Ultrasound Parameters

Phase 4

Completed

• Conditions: PCOS
• Interventions: Dietary Supplement: Myo-inositol + Folic acid; Dietary Supplement: D-chiro-inositol, manganese, folic acid, vit B12; Drug: Folic acid, vit B12

• Registration Number: NCT01514942
• Lead Sponsor: AGUNCO Obstetrics and Gynecology Centre

Brief Summary

Insulin resistance has important implications in the pathogenesis of the polycystic ovary syndrome (PCOS) and insulin-sensitizing drugs are considered a useful therapeutic approach.

Reduction of insulin levels with administration of insulin sensitizing agents has been found to be beneficial in lowering both hyperinsulinemia, hyperandrogenemia, and restoring ovulation. Metformin alone or in combination with oral contraceptives (OCs) has been widely used in the long term treatment of women with PCOS in whom it modifies the ovarian morphology, improves intraovarian androgen levels, and enhances systemic and local insulin resistance. Despite to these beneficial effects, several side effects have been reported due to the long term administration of this drug.

In the recent years, inositol has found more and more space in the reproductive clinical practice. Indeed, inositol have been classified as "insulin sensitizing agent" and it is mainly used as a chronic treatment for PCOS. Inositol exists in 9 different isomers and in particular several studies on Myo-inositol and D-chiro-inositol were reported.

In this study myo-inositol versus D-chiro-inositol treatments were compared to placebo in women with PCOS and with or without insulin resistance.

Detailed Description

Not available

Study Timeline

• Status Verified: 2012-01
• Study First Submitted: 2012-01-13
• Study First Submitted QC: 2012-01-18
• Last Update Submitted: 2012-01-18
• Study First Posted: 2012-01-23
• Last Update Posted: 2012-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

• Women fulfilled two out of three diagnostic criteria for PCOS

Exclusion Criteria

• Women with pre-existing secondary endocrine disorders
• Women with personal history of hypertension, diabetes mellitus or cardiovascular disorders
• Women who received treatment with other drugs for the previous 6 months before entering the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Insulin resistant patients	Folic acid, vit B12	-
Insulin resistant patients	D-chiro-inositol, manganese, folic acid, vit B12	-
Insulin resistant patients	Myo-inositol + Folic acid	-
Non-insulin resistant patients	Myo-inositol + Folic acid	-
Non-insulin resistant patients	D-chiro-inositol, manganese, folic acid, vit B12	-
Non-insulin resistant patients	Folic acid, vit B12	-

Primary Outcome Measures

Name	Time	Method
Body Mass Index (BMI)
Menstrual cycle
Score acne (acne grading system by Cremoncini et al)
Score hirsutism (Ferriman-Gallwey score)
Alopecia
Oral Glucose Tolerance Test (OGTT)
Glucagon levels
C-peptide test
Myo-inositol serum concentration
D-chiro-inositol serum concentration
Luteinizing Hormone (LH), Follicle Stimulating Hormone (FSH), and Estradiol (E2) levels test
Prolactin (PRL) levels test
Thyroid-stimulating hormone (TSH), free thyroid hormone (fT3 and fT4), and alpha-1 antitrypsin (AAT) test
Total and free testosterone levels
Sex hormone binding globulin (SHBG) test
17-Hydroxyprogesterone (17-OHP) levels
Dehydroepiandrosterone (DHEA) and DHEA-sulfate (DHEAS) levels
delta 4-androstenedione levels
progesterone levels
Adrenocorticotropic Hormone (ACTH) stimulation test
Ovarian size and morphology		Ovarian ultrasound scan for the assessment of size and morphology
Antral follicle counts
Stromal/Cortical ratio in the ovary
Endometrial thickness		Transvaginal ultrasound measurement of endometrial thickness performed between day 3 and 5 of the menstrual cycle.

Trial Locations

Locations (1)

Istituto di Patologia Ostetrica e Ginecologica; 🇮🇹 Catania, Italy