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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Lo.Li.Pharma s.r.l.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Lo.Li.Pharma s.r.l
ClinicalTrials.gov Identifier:
NCT01626443
First received: June 15, 2012
Last updated: October 18, 2012
Last verified: June 2012
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on August 28, 2014