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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AGUNCO Obstetrics and Gynecology Centre
ClinicalTrials.gov Identifier:
NCT01514942
First received: January 13, 2012
Last updated: January 18, 2012
Last verified: January 2012
History of Changes
  Purpose

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 Intervention 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AGUNCO Obstetrics and Gynecology Centre:

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

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


Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01514942

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

Publications:

Responsible Party: AGUNCO Obstetrics and Gynecology Centre
ClinicalTrials.gov Identifier: NCT01514942     History of Changes
Other Study ID Numbers: MIvsDCI_PCOS/IR
Study First Received: January 13, 2012
Last Updated: January 18, 2012
Health Authority: Italy: Ministry of Health

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
Folic Acid
Vitamin B Complex
 Hydroxocobalamin
Vitamin B 12
Inositol
Hematinics
Manganese
Insulin
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Hematologic Agents
Therapeutic Uses
Hypoglycemic Agents
Trace Elements

ClinicalTrials.gov processed this record on May 23, 2013