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

Purpose

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	Intervention	Phase
PCOS	Dietary Supplement: Myo-inositol + D-chiro-inositol + Folic acid Dietary Supplement: Folic acid	Phase 4

Study Type:

Interventional

Resource links provided by NLM:

MedlinePlus related topics: B Vitamins Diabetes Medicines

Drug Information available for: Folic acid Inositol Vitamin B Complex

U.S. FDA Resources

Further study details as provided by Lo.Li.Pharma s.r.l:

Primary Outcome Measures:

Menstrual cycle restoration
Score hirsutism (Ferriman-Gallwey classification)
Serum progesterone
Testosterone level test
Oral glucose tolerance test (OGTT)
Evaluation of glycemia and insulinemia levels
Homeostasis Model Assessment (HOMA-index)
Sex hormone binding globulin (SHBG) test
Androstenediol level test
Androstenedione level test
Free Androgen Index (FAI) level test

Secondary Outcome Measures:

Body Mass Index (BMI) [ Time Frame: three and six months ]
Change from baseline in diastolic blood pressure levels [ Time Frame: three and six months ]
Change from baseline in systolic blood pressure levels [ Time Frame: three and six months ]
Number of patients with abnormal ovarian size and morphology
Ovarian ultrasound scan for the assessment of size and morphology
Luteinizing Hormone (LH) level test
Analysis of LH levels should be performed between the 7th and the 10th day of the cycle
Follicle Stimulating Hormone (FSH) level test
Analysis of FSH levels should be performed between the 7th and the 10th day of the cycle
Estradiol (E2) level test
Analysis of E2 levels should be performed between the 7th and the 10th day of the cycle

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	14 Years to 40 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01626443

Contacts

Contact: Elena Bonelli

elena684@interfree.it

Locations

Italy
University of Pisa - Department of Endocrinology	Recruiting
Pisa, Italy
Contact: Elena Bonelli

Sponsors and Collaborators

Lo.Li.Pharma s.r.l

More Information

Publications:

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.

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.

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. Epub 2008 Mar 29.

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.

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.

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.

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.

Responsible Party:	Lo.Li.Pharma s.r.l
ClinicalTrials.gov Identifier:	NCT01626443 History of Changes
Other Study ID Numbers:	MI-DCI
Study First Received:	June 15, 2012
Last Updated:	October 18, 2012
Health Authority:	Italy: Ministry of Health

Keywords provided by Lo.Li.Pharma s.r.l:

PCOS
Metabolic disorders
Ovarian functionality
Myo-inositol
D-chiro-inositol

Additional relevant MeSH terms:

Folic Acid
Vitamin B Complex
Inositol
Hematinics
Vitamins
Micronutrients

Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013