Role of Myo-inositol and D-chiro Inositol on the Ovaric and Metabolic Functions

PCOS Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01626443
• Other study ID #: MI-DCI
• Status: Completed
• Phase: Phase 4
• First received: June 15, 2012
• Last updated: February 13, 2017
• Start date: January 2014
• Est. completion date: June 2015

Study information

• Verified date: February 2017
• Source: Lo.Li.Pharma s.r.l
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 14 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• PCOS

Intervention

Dietary Supplement:
• Myo-inositol + D-chiro-inositol + Folic acid
Myo-inositol (550 mg) + D-chiro-inositol (13.8 mg) + Folic acid (200 mcg); 2 x die
• Folic acid
Folic acid (200 mcg); 2 x die

Locations

Country	Name	City	State
Italy	University of Pisa - Department of Endocrinology	Pisa

Sponsors (1)

Lead Sponsor	Collaborator
Lo.Li.Pharma s.r.l

Country where clinical trial is conducted

Italy, 

References & Publications (7)

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. — View 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. — View Citation

Diamanti-Kandarakis E, Kouli CR, Bergiele AT, Filandra FA, Tsianateli TC, Spina GG, Zapanti ED, Bartzis MI. A survey of the polycystic ovary syndrome in the Greek island of Lesbos: hormonal and metabolic profile. J Clin Endocrinol Metab. 1999 Nov;84(11):4006-11. — View 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. Review. — View 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. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Menstrual cycle restoration		At 6 months
Primary	Score hirsutism (Ferriman-Gallwey classification)		At 6 months
Primary	Serum progesterone		At 6 months
Primary	Testosterone level test		At 6 months
Primary	Oral glucose tolerance test (OGTT)	Evaluation of glycemia and insulinemia levels	At 6 months
Primary	Homeostasis Model Assessment (HOMA-index)		At 6 months
Primary	Sex hormone binding globulin (SHBG) test		At 6 months
Primary	Androstenediol level test		At 6 months
Primary	Androstenedione level test		At 6 months
Primary	Free Androgen Index (FAI) level test		At 6 months
Secondary	Body Mass Index (BMI)		At 6 months
Secondary	Change from baseline in diastolic blood pressure levels		At 6 months
Secondary	Change from baseline in systolic blood pressure levels		At 6 months
Secondary	Number of patients with abnormal ovarian size and morphology	Ovarian ultrasound scan for the assessment of size and morphology	At 6 months
Secondary	Luteinizing Hormone (LH) level test	Analysis of LH levels should be performed between the 7th and the 10th day of the cycle	At 6 months
Secondary	Follicle Stimulating Hormone (FSH) level test	Analysis of FSH levels should be performed between the 7th and the 10th day of the cycle	At 6 months
Secondary	Estradiol (E2) level test	Analysis of E2 levels should be performed between the 7th and the 10th day of the cycle	At 6 months