Clinical trial NCT01514942: Myo-inositol Versus D-chiro-inositol in the Treatment of Polycystic Ovary Syndrome and Insulin Resistance: Evaluation of Clinical, Metabolic, Endocrine and Ultrasound Parameters
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: PCOS
Keywords: PCOS
Insulin resistance
Myo-inositol
D-chiro-inositol
Lead sponsor: AGUNCO Obstetrics and Gynecology Centre
Sponsor class: OTHER
First posted: 2012-01-23
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Body Mass Index (BMI)
measure: Menstrual cycle
measure: Score acne (acne grading system by Cremoncini et al)
measure: Score hirsutism (Ferriman-Gallwey score)
measure: Alopecia
measure: Oral Glucose Tolerance Test (OGTT)
measure: Glucagon levels
measure: C-peptide test
measure: Myo-inositol serum concentration
measure: D-chiro-inositol serum concentration
measure: Luteinizing Hormone (LH), Follicle Stimulating Hormone (FSH), and Estradiol (E2) levels test
measure: Prolactin (PRL) levels test
measure: Thyroid-stimulating hormone (TSH), free thyroid hormone (fT3 and fT4), and alpha-1 antitrypsin (AAT) test
measure: Total and free testosterone levels
measure: Sex hormone binding globulin (SHBG) test
measure: 17-Hydroxyprogesterone (17-OHP) levels
measure: Dehydroepiandrosterone (DHEA) and DHEA-sulfate (DHEAS) levels
measure: delta 4-androstenedione levels
measure: progesterone levels
measure: Adrenocorticotropic Hormone (ACTH) stimulation test
measure: Ovarian size and morphology
measure: Antral follicle counts
measure: Stromal/Cortical ratio in the ovary
measure: Endometrial thickness
Secondary outcomes:
Other outcomes:
Locations:
city: Catania
country: Italy
facility: Istituto di Patologia Ostetrica e Ginecologica
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.