Myoinositol Treatment and Asprosin Levels in PCOS

Study Overview
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Brief Summary
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Policystic ovary syndrome is the most common endocrinopthy during reproductive period. One of the factors implicated in the pathogenesis is insulin resistance. Asprosin, which is secreted from white adipose tissue is a new candidate for insulin resistance. Myoinositol is known to reduce insulin resistance in PCOS patients. The effect of myoinsitol on serum asprosin levels is unknown yet. This study aimed to evaluate the effect of myoinositol on serum asprosin levels in PCOS patients.

Detailed Description
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In addition to being the most common reproductive endocrinopathy in the population, polycystic ovary syndrome (PCOS) also carries a significantly increased risk for metabolic syndrome and type 2 diabetes. Insulin resistance and hyperinsulinemia are common findings in women with PCOS and are among the most contributing factors to hyperandrogenism in PCOS. This situation directly increases both ovarian and adrenal androgen release. Because of the pathophysiological link between insulin resistance and PCOS, insulin sensitizers have been used in treatment of the disease through this mechanism. Metformin is the most common insulin sensitizer used in many countries for type 2 diabetes and non-diabetic patients with high insulin resistance with PCOS in the last 50 years. Current evidence suggests that metformin may have metabolic and reproductive system benefits, such as weight loss, insulin resistance, and reduction of androgen levels, as well as restoration of normal menstrual cycle and ovulation. However, major side effects such as nausea, vomiting, and gastrointestinal discomfort limit metformin use. The poor compliance observed with metformin use has prompted clinicians worldwide to find new approaches for PCOS. Myo-inositol (MI) and d-chiro-inositol (DCI) are two of the 9 isomers of vitamin B6. MI and DCI, a naturally occurring compound, has been increasingly investigated over the past decade for its insulin sensitizing effects. As the postreceptor second messenger of the insulin signal, it interacts with GLUT4 via membrane-bound sodium-dependent channels and reduces hyperinsulinemia. Also, MI improves ovarian function, decreases lutinizing hormone / follicle stimulating hormone (LH / FSH) ratio, serum androgens, total testosterone and free testosterone levels. Asprosin is a newly discovered peptide hormone associated with insulin resistance and increases hepatic glucose production. Produced from abnormally increased white adipose tissue in insulin resistant mammals. A recent study found that serum asprosin levels were elevated in PCOS patients and this was positively correlated with insulin resistance. Based on these data, it has been suggested that the known positive effects of MI + DCI (inofolic combi) and metformin treatments on insulin resistance may also be on serum asprosin levels. This effect will be demonstrated with this study. In this study, it was aimed to investigate and to compare the change on serum asprosin levels in patients with polycystic ovary syndrome after the treatment with metformin or myo-inositol + d-chiro inositol + folic acid.

Official Title
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Effect of Myoinositol on Serum Asprosin Levels in PCOS Patients

Conditions
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PCOS, Insulin Resistance

Intervention / Treatment
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* Drug: inofolic combi
* Drug: Glucophage 500Mg Tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Polycystic ovary syndrome patients between 18-40 ages Exclusion Criteria: Tiroid disease Cardiovascular disease Diabetes mellitus Smoking Using insulin sensitizing drugs

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Myoinositol+D-chiroinositol+folic acid group<br>This group is given myoinositol+d-chiro inositol+folic acid once a day (inofolic combi, ITF company, Italy) (myoinositol 550 miligram+ d-chiroinositol 13,8 miligram+folic acid 200 micrograms) | Drug: inofolic combi<br>* The patients in this group were given inofolic combi once a day for 12-16 weeks<br>* Other names: inofolic combi, ITF company;|
| Experimental: Metformin group<br>This group is given metformin 500 miligram three times a day (glucophage 500mg, Merck company, Turkey) (total dose of metformin 1500 miligram a day) | Drug: Glucophage 500Mg Tablet<br>* The patients in this group were given glucophage three times a day for 12-16 weeks<br>* Other names: glucophage, Merck company;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum asprosin levels 1 | First measurement of serum asprosin level at initial examination | Second or third day of menstruation | 
| Serum asprosin levels 2 | Serum asprosin levels after 12-16 weeks from initial examination | After 12-16 weeks from first examination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Polycystic ovary syndrome, Myoinositol, Metformin, Insulin resistance, Asprosin