Clinical trial NCT01626443: Role of Myo-inositol and D-chiro Inositol on the Ovaric and Metabolic Functions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: PCOS
Keywords: PCOS
Metabolic disorders
Ovarian functionality
Myo-inositol
D-chiro-inositol
Lead sponsor: Lo.Li.Pharma s.r.l
Sponsor class: INDUSTRY
First posted: 2012-06-22
Enrollment: 46
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Polycystic ovary syndrome (PCOS) is one of the most common endocrine disorders in women of reproductive age and is characterized by menstrual abnormalities, clinical or biochemical hyperandrogenism, multiple abnormal cysts and enlarge ovaries. Women affected by PCOS often suffer of insulin resistance and of a compensatory hyperinsulinemia which put them at risk of developing several metabolic disorders. Inositol is a six-carbon polyol which has been characterized as an insulin sensitizer: it exists as nine different isomers and among them myo-inositol and D-chiroinositol are the most represented and studied in physiology and physiopathology. In particular, myo-inositol (MI) and D-chiro inositol (DCI) glycans administration has been reported to exert beneficial effects at metabolic, hormonal and ovarian levels.

The aim of this randomized study is to evaluate the metabolic and ovaric effects of a six-month supplementation of myo-inositol and D-chiro-inositol on young women with PCOS and hyperinsulemia.


Eligibility criteria: Inclusion Criteria:

* PCOS
* Women aged between 14-40 years
* BMI \> 28
* Hyperinsulinemia

Exclusion Criteria:

* Pre-existing secondary endocrine and metabolic disorders
* Pre-existing secondary adrenal disorders
* Pharmacologic treatment in the last 3 months before entering the study
* Pregnancy

Primary outcomes:
measure: Menstrual cycle restoration
timeFrame: At 6 months
measure: Score hirsutism (Ferriman-Gallwey classification)
timeFrame: At 6 months
measure: Serum progesterone
timeFrame: At 6 months
measure: Testosterone level test
timeFrame: At 6 months
measure: Oral glucose tolerance test (OGTT)
timeFrame: At 6 months
measure: Homeostasis Model Assessment (HOMA-index)
timeFrame: At 6 months
measure: Sex hormone binding globulin (SHBG) test
timeFrame: At 6 months
measure: Androstenediol level test
timeFrame: At 6 months
measure: Androstenedione level test
timeFrame: At 6 months
measure: Free Androgen Index (FAI) level test
timeFrame: At 6 months
Secondary outcomes:
measure: Body Mass Index (BMI)
timeFrame: At 6 months
measure: Change from baseline in diastolic blood pressure levels
timeFrame: At 6 months
measure: Change from baseline in systolic blood pressure levels
timeFrame: At 6 months
measure: Number of patients with abnormal ovarian size and morphology
timeFrame: At 6 months
measure: Luteinizing Hormone (LH) level test
timeFrame: At 6 months
measure: Follicle Stimulating Hormone (FSH) level test
timeFrame: At 6 months
measure: Estradiol (E2) level test
timeFrame: At 6 months
Other outcomes:
Locations:
city: Pisa
country: Italy
facility: University of Pisa - Department of Endocrinology
Study officials:
References:
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citation: Nestler JE. Role of hyperinsulinemia in the pathogenesis of the polycystic ovary syndrome, and its clinical implications. Semin Reprod Endocrinol. 1997 May;15(2):111-22. doi: 10.1055/s-2007-1016294.
citation: Baillargeon JP, Nestler JE, Ostlund RE, Apridonidze T, Diamanti-Kandarakis E. Greek hyperinsulinemic women, with or without polycystic ovary syndrome, display altered inositols metabolism. Hum Reprod. 2008 Jun;23(6):1439-46. doi: 10.1093/humrep/den097. Epub 2008 Mar 29.
citation: Nestler JE, Jakubowicz DJ, Reamer P, Gunn RD, Allan G. Ovulatory and metabolic effects of D-chiro-inositol in the polycystic ovary syndrome. N Engl J Med. 1999 Apr 29;340(17):1314-20. doi: 10.1056/NEJM199904293401703.
citation: Chiu TT, Rogers MS, Law EL, Briton-Jones CM, Cheung LP, Haines CJ. Follicular fluid and serum concentrations of myo-inositol in patients undergoing IVF: relationship with oocyte quality. Hum Reprod. 2002 Jun;17(6):1591-6. doi: 10.1093/humrep/17.6.1591.
citation: Vermeulen A, Verdonck L, Kaufman JM. A critical evaluation of simple methods for the estimation of free testosterone in serum. J Clin Endocrinol Metab. 1999 Oct;84(10):3666-72. doi: 10.1210/jcem.84.10.6079.
citation: Legro RS, Castracane VD, Kauffman RP. Detecting insulin resistance in polycystic ovary syndrome: purposes and pitfalls. Obstet Gynecol Surv. 2004 Feb;59(2):141-54. doi: 10.1097/01.OGX.0000109523.25076.E2.