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Myoinositol Treatment and Asprosin Levels in PCOS

Effect of Myoinositol on Serum Asprosin Levels in PCOS Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05951309
Enrollment
30
Registered
2023-07-19
Start date
2021-09-01
Completion date
2023-06-03
Last updated
2023-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PCOS, Insulin Resistance

Keywords

Polycystic ovary syndrome, Myoinositol, Metformin, Insulin resistance, Asprosin

Brief summary

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

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.

Interventions

The patients in this group were given inofolic combi once a day for 12-16 weeks

The patients in this group were given glucophage three times a day for 12-16 weeks

Sponsors

Near East University, Turkey
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No

Inclusion criteria

* Polycystic ovary syndrome patients between 18-40 ages

Exclusion criteria

* Tiroid disease * Cardiovascular disease * Diabetes mellitus * Smoking * Using insulin sensitizing drugs

Design outcomes

Primary

MeasureTime frameDescription
Serum asprosin levels 1Second or third day of menstruationFirst measurement of serum asprosin level at initial examination
Serum asprosin levels 2After 12-16 weeks from first examinationSerum asprosin levels after 12-16 weeks from initial examination

Countries

Cyprus

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026