Myoinositol Treatment and Asprosin Levels in PCOS

Insulin Resistance Clinical Trial

Official title:

Effect of Myoinositol on Serum Asprosin Levels in PCOS Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05951309
• Other study ID #: Asprosin-PCOS
• Status: Completed
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: June 3, 2023

Study information

• Verified date: July 2023
• Source: Near East University, Turkey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 3, 2023
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Polycystic ovary syndrome patients between 18-40 ages

Exclusion Criteria:

• Tiroid disease

• Cardiovascular disease

• Diabetes mellitus

• Smoking

• Using insulin sensitizing drugs

Related Conditions & MeSH terms

• Insulin Resistance
• Marfan Syndrome
• PCOS

Intervention

Drug:
• inofolic combi
The patients in this group were given inofolic combi once a day for 12-16 weeks
• Glucophage 500Mg Tablet
The patients in this group were given glucophage three times a day for 12-16 weeks

Locations

Country	Name	City	State
Cyprus	Near East University Faculty of Medicine	Nicosia

Sponsors (1)

Lead Sponsor	Collaborator
Near East University, Turkey

Country where clinical trial is conducted

Cyprus, 

References & Publications (11)

Alan M, Gurlek B, Yilmaz A, Aksit M, Aslanipour B, Gulhan I, Mehmet C, Taner CE. Asprosin: a novel peptide hormone related to insulin resistance in women with polycystic ovary syndrome. Gynecol Endocrinol. 2019 Mar;35(3):220-223. doi: 10.1080/09513590.2018.1512967. Epub 2018 Oct 16. — View Citation

Bargiota A, Diamanti-Kandarakis E. The effects of old, new and emerging medicines on metabolic aberrations in PCOS. Ther Adv Endocrinol Metab. 2012 Feb;3(1):27-47. doi: 10.1177/2042018812437355. — View Citation

Carlomagno G, Unfer V. Inositol safety: clinical evidences. Eur Rev Med Pharmacol Sci. 2011 Aug;15(8):931-6. — View Citation

Diamanti-Kandarakis E, Dunaif A. Insulin resistance and the polycystic ovary syndrome revisited: an update on mechanisms and implications. Endocr Rev. 2012 Dec;33(6):981-1030. doi: 10.1210/er.2011-1034. Epub 2012 Oct 12. — View Citation

Emekci Ozay O, Ozay AC, Cagliyan E, Okyay RE, Gulekli B. Myo-inositol administration positively effects ovulation induction and intrauterine insemination in patients with polycystic ovary syndrome: a prospective, controlled, randomized trial. Gynecol Endocrinol. 2017 Jul;33(7):524-528. doi: 10.1080/09513590.2017.1296127. Epub 2017 Mar 3. — View Citation

Fulghesu AM, Romualdi D, Di Florio C, Sanna S, Tagliaferri V, Gambineri A, Tomassoni F, Minerba L, Pasquali R, Lanzone A. Is there a dose-response relationship of metformin treatment in patients with polycystic ovary syndrome? Results from a multicentric study. Hum Reprod. 2012 Oct;27(10):3057-66. doi: 10.1093/humrep/des262. Epub 2012 Jul 10. — View Citation

Goodarzi MO, Korenman SG. The importance of insulin resistance in polycystic ovary syndrome. Fertil Steril. 2003 Aug;80(2):255-8. doi: 10.1016/s0015-0282(03)00734-9. No abstract available. — View Citation

Kirpichnikov D, McFarlane SI, Sowers JR. Metformin: an update. Ann Intern Med. 2002 Jul 2;137(1):25-33. doi: 10.7326/0003-4819-137-1-200207020-00009. — View Citation

Li X, Liao M, Shen R, Zhang L, Hu H, Wu J, Wang X, Qu H, Guo S, Long M, Zheng H. Plasma Asprosin Levels Are Associated with Glucose Metabolism, Lipid, and Sex Hormone Profiles in Females with Metabolic-Related Diseases. Mediators Inflamm. 2018 Nov 6;2018:7375294. doi: 10.1155/2018/7375294. eCollection 2018. — View Citation

Ozay AC, Emekci Ozay O, Okyay RE, Cagliyan E, Kume T, Gulekli B. Different Effects of Myoinositol plus Folic Acid versus Combined Oral Treatment on Androgen Levels in PCOS Women. Int J Endocrinol. 2016;2016:3206872. doi: 10.1155/2016/3206872. Epub 2016 Nov 2. Erratum In: Int J Endocrinol. 2018 Sep 10;2018:7502102. — View Citation

Palomba S, Falbo A, Zullo F, Orio F Jr. Evidence-based and potential benefits of metformin in the polycystic ovary syndrome: a comprehensive review. Endocr Rev. 2009 Feb;30(1):1-50. doi: 10.1210/er.2008-0030. Epub 2008 Dec 4. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum asprosin levels 1	First measurement of serum asprosin level at initial examination	Second or third day of menstruation
Primary	Serum asprosin levels 2	Serum asprosin levels after 12-16 weeks from initial examination	After 12-16 weeks from first examination