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

Tracking Information
First Received Date ^ICMJE	January 13, 2012
Last Updated Date	January 18, 2012
Start Date ^ICMJE	Not Provided
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE (submitted: January 18, 2012)	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.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01514942 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Myo-inositol Versus D-chiro-inositol in the Treatment of Polycystic Ovary Syndrome and Insulin Resistance: Evaluation of Clinical, Metabolic, Endocrine and Ultrasound Parameters
Official Title ^ICMJE	Not Provided
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Not Provided
Condition ^ICMJE	PCOS
Intervention ^ICMJE	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) 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)
Study Arm (s)	Insulin resistant patients Interventions: 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 Interventions: Dietary Supplement: Myo-inositol + Folic acid Dietary Supplement: D-chiro-inositol, manganese, folic acid, vit B12 Drug: Folic acid, vit B12
Publications *	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. 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. 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. 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. Epub 2010 Aug 27. Review.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	Not Provided
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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.
Gender	Female
Ages	20 Years to 40 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Italy

Administrative Information
NCT Number ^ICMJE	NCT01514942
Other Study ID Numbers ^ICMJE	MIvsDCI_PCOS/IR
Has Data Monitoring Committee	Not Provided
Responsible Party	AGUNCO Obstetrics and Gynecology Centre
Study Sponsor ^ICMJE	AGUNCO Obstetrics and Gynecology Centre
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	AGUNCO Obstetrics and Gynecology Centre
Verification Date	January 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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