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Completed

NCT Number: NCT01626443

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

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.

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Key information

Conditions

PCOS Metabolic Diseases Nutritional and Metabolic Diseases

Age range

14 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

University of Pisa - Department of Endocrinology

Pisa, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Folic Acid

Dietary Supplement

Folic acid (200 mcg); 2 x die

Primary outcomes

  1. Menstrual cycle restoration

    Time frame: At 6 months

  2. Score hirsutism (Ferriman-Gallwey classification)

    Time frame: At 6 months

  3. Serum progesterone

    Time frame: At 6 months

  4. Testosterone level test

    Time frame: At 6 months

  5. Oral glucose tolerance test (OGTT)

    Time frame: At 6 months

    Evaluation of glycemia and insulinemia levels

  6. Homeostasis Model Assessment (HOMA-index)

    Time frame: At 6 months

  7. Sex hormone binding globulin (SHBG) test

    Time frame: At 6 months

  8. Androstenediol level test

    Time frame: At 6 months

  9. Androstenedione level test

    Time frame: At 6 months

  10. Free Androgen Index (FAI) level test

    Time frame: At 6 months

Secondary outcomes

  1. Body Mass Index (BMI)

    Time frame: At 6 months

  2. Change from baseline in diastolic blood pressure levels

    Time frame: At 6 months

  3. Change from baseline in systolic blood pressure levels

    Time frame: At 6 months

  4. Number of patients with abnormal ovarian size and morphology

    Time frame: At 6 months

    Ovarian ultrasound scan for the assessment of size and morphology

  5. Luteinizing Hormone (LH) level test

    Time frame: At 6 months

    Analysis of LH levels should be performed between the 7th and the 10th day of the cycle

  6. Follicle Stimulating Hormone (FSH) level test

    Time frame: At 6 months

    Analysis of FSH levels should be performed between the 7th and the 10th day of the cycle

  7. Estradiol (E2) level test

    Time frame: At 6 months

    Analysis of E2 levels should be performed between the 7th and the 10th day of the cycle

Sponsors and collaborators

Lead sponsor

Lo.Li.Pharma s.r.l

Industry

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jun 22, 2012
Registry last updated
Feb 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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