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Myoinositol Treatment and Asprosin Levels in PCOS

Primary Purpose

PCOS, Insulin Resistance

Status
Completed
Phase
Not Applicable
Locations
Cyprus
Study Type
Interventional
Intervention
inofolic combi
Glucophage 500Mg Tablet
Sponsored by
Near East University, Turkey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for PCOS focused on measuring Polycystic ovary syndrome, Myoinositol, Metformin, Insulin resistance, Asprosin

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Near East University Faculty of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Myoinositol+D-chiroinositol+folic acid group

Metformin group

Arm Description

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)

This group is given metformin 500 miligram three times a day (glucophage 500mg, Merck company, Turkey) (total dose of metformin 1500 miligram a day)

Outcomes

Primary Outcome Measures

Serum asprosin levels 1
First measurement of serum asprosin level at initial examination
Serum asprosin levels 2
Serum asprosin levels after 12-16 weeks from initial examination

Secondary Outcome Measures

Full Information

First Posted
July 3, 2023
Last Updated
July 10, 2023
Sponsor
Near East University, Turkey
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1. Study Identification

Unique Protocol Identification Number
NCT05951309
Brief Title
Myoinositol Treatment and Asprosin Levels in PCOS
Official Title
Effect of Myoinositol on Serum Asprosin Levels in PCOS Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
September 30, 2022 (Actual)
Study Completion Date
June 3, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Near East University, Turkey

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PCOS, Insulin Resistance
Keywords
Polycystic ovary syndrome, Myoinositol, Metformin, Insulin resistance, Asprosin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Myoinositol+D-chiroinositol+folic acid group
Arm Type
Experimental
Arm Description
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)
Arm Title
Metformin group
Arm Type
Experimental
Arm Description
This group is given metformin 500 miligram three times a day (glucophage 500mg, Merck company, Turkey) (total dose of metformin 1500 miligram a day)
Intervention Type
Drug
Intervention Name(s)
inofolic combi
Other Intervention Name(s)
inofolic combi, ITF company
Intervention Description
The patients in this group were given inofolic combi once a day for 12-16 weeks
Intervention Type
Drug
Intervention Name(s)
Glucophage 500Mg Tablet
Other Intervention Name(s)
glucophage, Merck company
Intervention Description
The patients in this group were given glucophage three times a day for 12-16 weeks
Primary Outcome Measure Information:
Title
Serum asprosin levels 1
Description
First measurement of serum asprosin level at initial examination
Time Frame
Second or third day of menstruation
Title
Serum asprosin levels 2
Description
Serum asprosin levels after 12-16 weeks from initial examination
Time Frame
After 12-16 weeks from first examination

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Polycystic ovary syndrome patients between 18-40 ages Exclusion Criteria: Tiroid disease Cardiovascular disease Diabetes mellitus Smoking Using insulin sensitizing drugs
Facility Information:
Facility Name
Near East University Faculty of Medicine
City
Nicosia
ZIP/Postal Code
99138
Country
Cyprus

12. IPD Sharing Statement

Citations:
PubMed Identifier
23065822
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.
Results Reference
background
PubMed Identifier
12909480
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.
Results Reference
background
PubMed Identifier
12093242
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.
Results Reference
background
PubMed Identifier
23148192
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.
Results Reference
background
PubMed Identifier
19056992
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.
Results Reference
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PubMed Identifier
22786777
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.
Results Reference
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PubMed Identifier
21845803
Citation
Carlomagno G, Unfer V. Inositol safety: clinical evidences. Eur Rev Med Pharmacol Sci. 2011 Aug;15(8):931-6.
Results Reference
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PubMed Identifier
27882049
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.
Results Reference
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PubMed Identifier
28277112
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.
Results Reference
background
PubMed Identifier
30524197
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.
Results Reference
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PubMed Identifier
30325247
Citation
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.
Results Reference
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Myoinositol Treatment and Asprosin Levels in PCOS

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