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

NCT01626443 | Completed Phase 4

• 1 other identifier: MI-DCI
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

PCOS

Keywords

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

Outcome Measures

Primary Outcomes (10)

• 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)

  Evaluation of glycemia and insulinemia levels

  At 6 months

• 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 Outcomes (7)

• 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

• Luteinizing Hormone (LH) level test

  At 6 months

Study Arms (2)

Folic acid

ACTIVE COMPARATOR

Dietary Supplement: Folic acid

Inofolic Combi

EXPERIMENTAL

Dietary Supplement: Myo-inositol + D-chiro-inositol + Folic acid

Interventions

Myo-inositol + D-chiro-inositol + Folic acid DIETARY_SUPPLEMENT

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

Inofolic Combi

Folic acid DIETARY_SUPPLEMENT

Folic acid (200 mcg); 2 x die

Folic acid

Eligibility Criteria

• Age: 14 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Lo.Li.Pharma s.r.l: lead

Study Sites (1)

University of Pisa - Department of Endocrinology

Pisa, Italy

Location

Related Publications (7)

• 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. doi: 10.1210/jcem.84.11.6148.

  PMID: 10566641 BACKGROUND

• 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.

  PMID: 9165656 BACKGROUND

• 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.

  PMID: 18375940 BACKGROUND

• 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.

  PMID: 10219066 BACKGROUND

• 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.

  PMID: 12042283 BACKGROUND

• 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.

  PMID: 10523012 BACKGROUND

• 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.

  PMID: 14752302 BACKGROUND

MeSH Terms

Conditions

Metabolic Diseases

Interventions

Inositol; Folic Acid

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2012
• First Posted: June 22, 2012
• Study Start: January 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: February 14, 2017

Record last verified: 2017-02

Locations

IT (1)