Myo-inositol Versus D-chiro-inositol in the Treatment of Polycystic Ovary Syndrome and Insulin Resistance: Evaluation of Clinical, Metabolic, Endocrine and Ultrasound Parameters
Primary Purpose
PCOS
Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Myo-inositol + Folic acid
Myo-inositol + Folic acid
D-chiro-inositol, manganese, folic acid, vit B12
D-chiro-inositol, manganese, folic acid, vit B12
Folic acid, vit B12
Folic acid, vit B12
Sponsored by
About this trial
This is an interventional trial for PCOS focused on measuring PCOS, Insulin resistance, Myo-inositol, D-chiro-inositol
Eligibility 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.
Sites / Locations
- Istituto di Patologia Ostetrica e Ginecologica
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Insulin resistant patients
Non-insulin resistant patients
Arm Description
Outcomes
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01514942
First Posted
January 13, 2012
Last Updated
January 18, 2012
Sponsor
AGUNCO Obstetrics and Gynecology Centre
1. Study Identification
Unique Protocol Identification Number
NCT01514942
Brief Title
Myo-inositol Versus D-chiro-inositol in the Treatment of Polycystic Ovary Syndrome and Insulin Resistance: Evaluation of Clinical, Metabolic, Endocrine and Ultrasound Parameters
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AGUNCO Obstetrics and Gynecology Centre
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PCOS
Keywords
PCOS, Insulin resistance, Myo-inositol, D-chiro-inositol
7. Study Design
Study Phase
Phase 4
8. Arms, Groups, and Interventions
Arm Title
Insulin resistant patients
Arm Type
Other
Arm Title
Non-insulin resistant patients
Arm Type
Other
Intervention Type
Dietary Supplement
Intervention Name(s)
Myo-inositol + Folic acid
Intervention Description
Myo-inositol (2g) Folic acid (200mcg) (2 per day)
Intervention Type
Dietary Supplement
Intervention Name(s)
Myo-inositol + Folic acid
Intervention Description
Myo-inositol (2g) Folic acid (200mcg) (2 per day)
Intervention Type
Dietary Supplement
Intervention Name(s)
D-chiro-inositol, manganese, folic acid, vit B12
Intervention Description
D-Chiro-inositol (500 mg), manganese (1 mg), folic acid (200 mcg), vit B12 (1.25 mcg) (2 per day)
Intervention Type
Dietary Supplement
Intervention Name(s)
D-chiro-inositol, manganese, folic acid, vit B12
Intervention Description
D-chiro-inositol (500 mg), manganese (1 mg), folic acid (200 mcg), vit B12 (1.25 mcg) (2 per day)
Intervention Type
Drug
Intervention Name(s)
Folic acid, vit B12
Intervention Description
Folic acid (200 mcg), vit B12 (1.25 mcg) (2 per day)
Intervention Type
Drug
Intervention Name(s)
Folic acid, vit B12
Intervention Description
Folic acid (200 mcg), vit B12 (1.25 mcg) (2 per day)
Primary Outcome Measure Information:
Title
Body Mass Index (BMI)
Title
Menstrual cycle
Title
Score acne (acne grading system by Cremoncini et al)
Title
Score hirsutism (Ferriman-Gallwey score)
Title
Alopecia
Title
Oral Glucose Tolerance Test (OGTT)
Title
Glucagon levels
Title
C-peptide test
Title
Myo-inositol serum concentration
Title
D-chiro-inositol serum concentration
Title
Luteinizing Hormone (LH), Follicle Stimulating Hormone (FSH), and Estradiol (E2) levels test
Title
Prolactin (PRL) levels test
Title
Thyroid-stimulating hormone (TSH), free thyroid hormone (fT3 and fT4), and alpha-1 antitrypsin (AAT) test
Title
Total and free testosterone levels
Title
Sex hormone binding globulin (SHBG) test
Title
17-Hydroxyprogesterone (17-OHP) levels
Title
Dehydroepiandrosterone (DHEA) and DHEA-sulfate (DHEAS) levels
Title
delta 4-androstenedione levels
Title
progesterone levels
Title
Adrenocorticotropic Hormone (ACTH) stimulation test
Title
Ovarian size and morphology
Description
Ovarian ultrasound scan for the assessment of size and morphology
Title
Antral follicle counts
Title
Stromal/Cortical ratio in the ovary
Title
Endometrial thickness
Description
Transvaginal ultrasound measurement of endometrial thickness performed between day 3 and 5 of the menstrual cycle.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Istituto di Patologia Ostetrica e Ginecologica
City
Catania
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
19499845
Citation
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.
Results Reference
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PubMed Identifier
20222840
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.
Results Reference
background
PubMed Identifier
11900279
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. doi: 10.1080/15604280212528.
Results Reference
background
PubMed Identifier
20811656
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.
Results Reference
background
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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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