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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insulin resistant patients | Other |
| |
| Non-insulin resistant patients | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Myo-inositol + Folic acid | Dietary Supplement | Myo-inositol (2g) Folic acid (200mcg) (2 per day) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | ||
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istituto di Patologia Ostetrica e Ginecologica | Catania | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19499845 | Background | Costantino D, Minozzi G, Minozzi E, Guaraldi C. Metabolic and hormonal effects of myo-inositol in women with polycystic ovary syndrome: a double-blind trial. Eur Rev Med Pharmacol Sci. 2009 Mar-Apr;13(2):105-10. | |
| 20222840 | Background | Raffone E, Rizzo P, Benedetto V. Insulin sensitiser agents alone and in co-treatment with r-FSH for ovulation induction in PCOS women. Gynecol Endocrinol. 2010 Apr;26(4):275-80. doi: 10.3109/09513590903366996. |
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| Myo-inositol + Folic acid | Dietary Supplement | Myo-inositol (2g) Folic acid (200mcg) (2 per day) |
|
| D-chiro-inositol, manganese, folic acid, vit B12 | Dietary Supplement | D-Chiro-inositol (500 mg), manganese (1 mg), folic acid (200 mcg), vit B12 (1.25 mcg) (2 per day) |
|
| D-chiro-inositol, manganese, folic acid, vit B12 | Dietary Supplement | D-chiro-inositol (500 mg), manganese (1 mg), folic acid (200 mcg), vit B12 (1.25 mcg) (2 per day) |
|
| Folic acid, vit B12 | Drug | Folic acid (200 mcg), vit B12 (1.25 mcg) (2 per day) |
|
| Folic acid, vit B12 | Drug | Folic acid (200 mcg), vit B12 (1.25 mcg) (2 per day) |
|
| 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. |
| 11900279 | Background | Larner J. D-chiro-inositol--its functional role in insulin action and its deficit in insulin resistance. Int J Exp Diabetes Res. 2002;3(1):47-60. doi: 10.1080/15604280212528. |
| 20811656 | Background | Larner J, Brautigan DL, Thorner MO. D-chiro-inositol glycans in insulin signaling and insulin resistance. Mol Med. 2010 Nov-Dec;16(11-12):543-52. doi: 10.2119/molmed.2010.00107. Epub 2010 Aug 27. |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D007294 | Inositol |
| D005492 | Folic Acid |
| D008345 | Manganese |
| D014805 | Vitamin B 12 |
| ID | Term |
|---|---|
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D002241 | Carbohydrates |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D028561 | Transition Elements |
| D008670 | Metals |
| D045728 | Corrinoids |
| D045725 | Tetrapyrroles |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
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