Role of Myo-inositol and D-chiro Inositol on the Ovaric and Metabolic Functions
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Folic acid
|
Dietary Supplement: Folic acid
Folic acid (200 mcg); 2 x die
|
| Experimental: Inofolic Combi
|
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
|
Outcome Measures
Primary Outcome Measures
- Menstrual cycle restoration [At 6 months]
- Score hirsutism (Ferriman-Gallwey classification) [At 6 months]
- Serum progesterone [At 6 months]
- Testosterone level test [At 6 months]
- Oral glucose tolerance test (OGTT) [At 6 months]
Evaluation of glycemia and insulinemia levels
- Homeostasis Model Assessment (HOMA-index) [At 6 months]
- Sex hormone binding globulin (SHBG) test [At 6 months]
- Androstenediol level test [At 6 months]
- Androstenedione level test [At 6 months]
- Free Androgen Index (FAI) level test [At 6 months]
Secondary Outcome Measures
- Body Mass Index (BMI) [At 6 months]
- Change from baseline in diastolic blood pressure levels [At 6 months]
- Change from baseline in systolic blood pressure levels [At 6 months]
- Number of patients with abnormal ovarian size and morphology [At 6 months]
Ovarian ultrasound scan for the assessment of size and morphology
- Luteinizing Hormone (LH) level test [At 6 months]
Analysis of LH levels should be performed between the 7th and the 10th day of the cycle
- Follicle Stimulating Hormone (FSH) level test [At 6 months]
Analysis of FSH levels should be performed between the 7th and the 10th day of the cycle
- Estradiol (E2) level test [At 6 months]
Analysis of E2 levels should be performed between the 7th and the 10th day of the cycle
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Pisa - Department of Endocrinology | Pisa | Italy |
Sponsors and Collaborators
- Lo.Li.Pharma s.r.l
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- MI-DCI