- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05951309
Myoinositol Treatment and Asprosin Levels in PCOS
Effect of Myoinositol on Serum Asprosin Levels in PCOS Patients
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Nicosia, Cyprus, 99138
- Near East University Faculty of Medicine
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Polycystic ovary syndrome patients between 18-40 ages
Exclusion Criteria:
- Tiroid disease
- Cardiovascular disease
- Diabetes mellitus
- Smoking
- Using insulin sensitizing drugs
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Myoinositol+D-chiroinositol+folic acid group
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)
|
The patients in this group were given inofolic combi once a day for 12-16 weeks
Other Names:
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Experimental: Metformin group
This group is given metformin 500 miligram three times a day (glucophage 500mg, Merck company, Turkey) (total dose of metformin 1500 miligram a day)
|
The patients in this group were given glucophage three times a day for 12-16 weeks
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Serum asprosin levels 1
Time Frame: Second or third day of menstruation
|
First measurement of serum asprosin level at initial examination
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Second or third day of menstruation
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Serum asprosin levels 2
Time Frame: After 12-16 weeks from first examination
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Serum asprosin levels after 12-16 weeks from initial examination
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After 12-16 weeks from first examination
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- Carlomagno G, Unfer V. Inositol safety: clinical evidences. Eur Rev Med Pharmacol Sci. 2011 Aug;15(8):931-6.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Heart Diseases
- Cardiovascular Diseases
- Glucose Metabolism Disorders
- Metabolic Diseases
- Congenital Abnormalities
- Genetic Diseases, Inborn
- Musculoskeletal Diseases
- Connective Tissue Diseases
- Hyperinsulinism
- Bone Diseases
- Heart Defects, Congenital
- Cardiovascular Abnormalities
- Abnormalities, Multiple
- Bone Diseases, Developmental
- Insulin Resistance
- Marfan Syndrome
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Metformin
Other Study ID Numbers
- Asprosin-PCOS
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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