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Completed

NCT Number: NCT05951309

Myoinositol Treatment and Asprosin Levels in PCOS

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.

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Key information

Conditions

PCOS Adnexal Diseases Arachnodactyly Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Glucose Metabolism Disorders Gonadal Disorders Hyperinsulinism Insulin Resistance Limb Deformities, Congenital Metabolic Diseases Musculoskeletal Abnormalities Musculoskeletal Diseases Neoplasms Nutritional and Metabolic Diseases Ovarian Cysts Ovarian Diseases Polycystic Ovary Syndrome Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Near East University Faculty of Medicine

Nicosia, 99138, Cyprus

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Polycystic ovary syndrome patients between 18-40 ages

Exclusion criteria

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

Treatment and study plan

inofolic combi

Drug

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

Other names: inofolic combi, ITF company

Glucophage 500Mg Tablet

Drug

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

Other names: glucophage, Merck company

Primary outcomes

  1. Serum asprosin levels 1

    Time frame: Second or third day of menstruation

    First measurement of serum asprosin level at initial examination

  2. Serum asprosin levels 2

    Time frame: After 12-16 weeks from first examination

    Serum asprosin levels after 12-16 weeks from initial examination

Sponsors and collaborators

Lead sponsor

Near East University, Turkey

Other

Registry information

Official study title

Effect of Myoinositol on Serum Asprosin Levels in PCOS Patients

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Jul 19, 2023
Registry last updated
Jul 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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