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

NCT01514942 | Completed Phase 4

• 1 other identifier: MIvsDCI_PCOS/IR
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

PCOS

Keywords

PCOS; Insulin resistance; Myo-inositol; D-chiro-inositol

Outcome Measures

Primary Outcomes (24)

• 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.

Study Arms (2)

Insulin resistant patients

OTHER

Dietary Supplement: Myo-inositol + Folic acid; Dietary Supplement: D-chiro-inositol, manganese, folic acid, vit B12; Drug: Folic acid, vit B12

Non-insulin resistant patients

OTHER

Dietary Supplement: Myo-inositol + Folic acid; Dietary Supplement: D-chiro-inositol, manganese, folic acid, vit B12; Drug: Folic acid, vit B12

Interventions

Myo-inositol + Folic acid DIETARY_SUPPLEMENT

Myo-inositol (2g) Folic acid (200mcg) (2 per day)

Insulin resistant patients

D-chiro-inositol, manganese, folic acid, vit B12 DIETARY_SUPPLEMENT

D-Chiro-inositol (500 mg), manganese (1 mg), folic acid (200 mcg), vit B12 (1.25 mcg) (2 per day)

Insulin resistant patients

Folic acid, vit B12 DRUG

Folic acid (200 mcg), vit B12 (1.25 mcg) (2 per day)

Insulin resistant patients

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women fulfilled two out of three diagnostic criteria for PCOS

You may not qualify if:

• 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.

Sponsors & Collaborators

• AGUNCO Obstetrics and Gynecology Centre: lead

Study Sites (1)

Istituto di Patologia Ostetrica e Ginecologica

Catania, Italy

Location

Related Publications (4)

• Costantino D, Minozzi G, Minozzi E, Guaraldi C. Metabolic and hormonal effects of myo-inositol in women with polycystic ovary syndrome: a double-blind trial. Eur Rev Med Pharmacol Sci. 2009 Mar-Apr;13(2):105-10.

  PMID: 19499845 BACKGROUND

• Raffone E, Rizzo P, Benedetto V. Insulin sensitiser agents alone and in co-treatment with r-FSH for ovulation induction in PCOS women. Gynecol Endocrinol. 2010 Apr;26(4):275-80. doi: 10.3109/09513590903366996.

  PMID: 20222840 BACKGROUND

• Larner J. D-chiro-inositol--its functional role in insulin action and its deficit in insulin resistance. Int J Exp Diabetes Res. 2002;3(1):47-60. doi: 10.1080/15604280212528.

  PMID: 11900279 BACKGROUND

• Larner J, Brautigan DL, Thorner MO. D-chiro-inositol glycans in insulin signaling and insulin resistance. Mol Med. 2010 Nov-Dec;16(11-12):543-52. doi: 10.2119/molmed.2010.00107. Epub 2010 Aug 27.

  PMID: 20811656 BACKGROUND

MeSH Terms

Conditions

Insulin Resistance

Interventions

Inositol; Folic Acid; Manganese; Vitamin B 12

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; 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; Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals; Corrinoids; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds, 4 or More Rings; Macrocyclic Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2012
• First Posted: January 23, 2012
• Last Updated: January 23, 2012

Record last verified: 2012-01

Locations

IT (1)