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Myo-inositol Versus D-chiro-inositol in the Treatment of Polycystic Ovary Syndrome and Insulin Resistance: Evaluation of Clinical, Metabolic, Endocrine and Ultrasound Parameters

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ClinicalTrials.gov Identifier: NCT01514942
Recruitment Status : Completed
First Posted : January 23, 2012
Last Update Posted : January 23, 2012
Sponsor:
Information provided by (Responsible Party):
AGUNCO Obstetrics and Gynecology Centre

Brief Summary:

Insulin resistance has important implications in the pathogenesis of the polycystic ovary syndrome (PCOS) and insulin-sensitizing drugs are considered a useful therapeutic approach.

Reduction of insulin levels with administration of insulin sensitizing agents has been found to be beneficial in lowering both hyperinsulinemia, hyperandrogenemia, and restoring ovulation. Metformin alone or in combination with oral contraceptives (OCs) has been widely used in the long term treatment of women with PCOS in whom it modifies the ovarian morphology, improves intraovarian androgen levels, and enhances systemic and local insulin resistance. Despite to these beneficial effects, several side effects have been reported due to the long term administration of this drug.

In the recent years, inositol has found more and more space in the reproductive clinical practice. Indeed, inositol have been classified as "insulin sensitizing agent" and it is mainly used as a chronic treatment for PCOS. Inositol exists in 9 different isomers and in particular several studies on Myo-inositol and D-chiro-inositol were reported.

In this study myo-inositol versus D-chiro-inositol treatments were compared to placebo in women with PCOS and with or without insulin resistance.


Condition or disease Intervention/treatment Phase
PCOS Dietary Supplement: Myo-inositol + Folic acid Dietary Supplement: D-chiro-inositol, manganese, folic acid, vit B12 Drug: Folic acid, vit B12 Phase 4

Study Type : Interventional  (Clinical Trial)

Resource links provided by the National Library of Medicine

Drug Information available for: Inositol
U.S. FDA Resources

Arm Intervention/treatment
Insulin resistant patients Dietary Supplement: Myo-inositol + Folic acid
Myo-inositol (2g) Folic acid (200mcg) (2 per day)
Dietary Supplement: D-chiro-inositol, manganese, folic acid, vit B12
D-Chiro-inositol (500 mg), manganese (1 mg), folic acid (200 mcg), vit B12 (1.25 mcg) (2 per day)
Drug: Folic acid, vit B12
Folic acid (200 mcg), vit B12 (1.25 mcg) (2 per day)
Non-insulin resistant patients Dietary Supplement: Myo-inositol + Folic acid
Myo-inositol (2g) Folic acid (200mcg) (2 per day)
Dietary Supplement: D-chiro-inositol, manganese, folic acid, vit B12
D-chiro-inositol (500 mg), manganese (1 mg), folic acid (200 mcg), vit B12 (1.25 mcg) (2 per day)
Drug: Folic acid, vit B12
Folic acid (200 mcg), vit B12 (1.25 mcg) (2 per day)



Primary Outcome Measures :
  1. Body Mass Index (BMI)
  2. Menstrual cycle
  3. Score acne (acne grading system by Cremoncini et al)
  4. Score hirsutism (Ferriman-Gallwey score)
  5. Alopecia
  6. Oral Glucose Tolerance Test (OGTT)
  7. Glucagon levels
  8. C-peptide test
  9. Myo-inositol serum concentration
  10. D-chiro-inositol serum concentration
  11. Luteinizing Hormone (LH), Follicle Stimulating Hormone (FSH), and Estradiol (E2) levels test
  12. Prolactin (PRL) levels test
  13. Thyroid-stimulating hormone (TSH), free thyroid hormone (fT3 and fT4), and alpha-1 antitrypsin (AAT) test
  14. Total and free testosterone levels
  15. Sex hormone binding globulin (SHBG) test
  16. 17-Hydroxyprogesterone (17-OHP) levels
  17. Dehydroepiandrosterone (DHEA) and DHEA-sulfate (DHEAS) levels
  18. delta 4-androstenedione levels
  19. progesterone levels
  20. Adrenocorticotropic Hormone (ACTH) stimulation test
  21. Ovarian size and morphology
    Ovarian ultrasound scan for the assessment of size and morphology

  22. Antral follicle counts
  23. Stromal/Cortical ratio in the ovary
  24. Endometrial thickness
    Transvaginal ultrasound measurement of endometrial thickness performed between day 3 and 5 of the menstrual cycle.



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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women fulfilled two out of three diagnostic criteria for PCOS

Exclusion Criteria:

  • Women with pre-existing secondary endocrine disorders
  • Women with personal history of hypertension, diabetes mellitus or cardiovascular disorders
  • Women who received treatment with other drugs for the previous 6 months before entering the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01514942


Locations
Italy
Istituto di Patologia Ostetrica e Ginecologica
Catania, Italy
Sponsors and Collaborators
AGUNCO Obstetrics and Gynecology Centre

Publications:
Responsible Party: AGUNCO Obstetrics and Gynecology Centre
ClinicalTrials.gov Identifier: NCT01514942     History of Changes
Other Study ID Numbers: MIvsDCI_PCOS/IR
First Posted: January 23, 2012    Key Record Dates
Last Update Posted: January 23, 2012
Last Verified: January 2012

Keywords provided by AGUNCO Obstetrics and Gynecology Centre:
PCOS
Insulin resistance
Myo-inositol
D-chiro-inositol

Additional relevant MeSH terms:
Insulin Resistance
Polycystic Ovary Syndrome
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Insulin
Folic Acid
Hydroxocobalamin
Vitamin B Complex
Vitamin B 12
Inositol
Manganese
Hypoglycemic Agents
Physiological Effects of Drugs
Hematinics
Vitamins
Micronutrients
Growth Substances
Trace Elements