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

PCOS Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01514942
• Other study ID #: MIvsDCI_PCOS/IR
• Status: Completed
• Phase: Phase 4
• First received: January 13, 2012
• Last updated: January 18, 2012

Study information

• Verified date: January 2012
• Source: AGUNCO Obstetrics and Gynecology Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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.

Study Design

N/A

Related Conditions & MeSH terms

• Insulin Resistance
• PCOS
• Polycystic Ovary Syndrome

Intervention

Dietary Supplement:
• Myo-inositol + Folic acid
Myo-inositol (2g) Folic acid (200mcg) (2 per day)
• Myo-inositol + Folic acid
Myo-inositol (2g) Folic acid (200mcg) (2 per day)
• 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)
• 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)
• Folic acid, vit B12
Folic acid (200 mcg), vit B12 (1.25 mcg) (2 per day)

Locations

Country	Name	City	State
Italy	Istituto di Patologia Ostetrica e Ginecologica	Catania

Sponsors (1)

Lead Sponsor	Collaborator
AGUNCO Obstetrics and Gynecology Centre

Country where clinical trial is conducted

Italy, 

References & 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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Mass Index (BMI)
Primary	Menstrual cycle
Primary	Score acne (acne grading system by Cremoncini et al)
Primary	Score hirsutism (Ferriman-Gallwey score)
Primary	Alopecia
Primary	Oral Glucose Tolerance Test (OGTT)
Primary	Glucagon levels
Primary	C-peptide test
Primary	Myo-inositol serum concentration
Primary	D-chiro-inositol serum concentration
Primary	Luteinizing Hormone (LH), Follicle Stimulating Hormone (FSH), and Estradiol (E2) levels test
Primary	Prolactin (PRL) levels test
Primary	Thyroid-stimulating hormone (TSH), free thyroid hormone (fT3 and fT4), and alpha-1 antitrypsin (AAT) test
Primary	Total and free testosterone levels
Primary	Sex hormone binding globulin (SHBG) test
Primary	17-Hydroxyprogesterone (17-OHP) levels
Primary	Dehydroepiandrosterone (DHEA) and DHEA-sulfate (DHEAS) levels
Primary	delta 4-androstenedione levels
Primary	progesterone levels
Primary	Adrenocorticotropic Hormone (ACTH) stimulation test
Primary	Ovarian size and morphology	Ovarian ultrasound scan for the assessment of size and morphology
Primary	Antral follicle counts
Primary	Stromal/Cortical ratio in the ovary
Primary	Endometrial thickness	Transvaginal ultrasound measurement of endometrial thickness performed between day 3 and 5 of the menstrual cycle.