NCT05951309

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 3, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 3, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 19, 2023

Completed
Last Updated

July 19, 2023

Status Verified

July 1, 2023

Enrollment Period

1.1 years

First QC Date

July 3, 2023

Last Update Submit

July 10, 2023

Conditions

PCOSInsulin Resistance

Keywords

Polycystic ovary syndromeMyoinositolMetforminInsulin resistanceAsprosin

Outcome Measures

Primary Outcomes (2)

  • Serum asprosin levels 1

    First measurement of serum asprosin level at initial examination

    Second or third day of menstruation

  • Serum asprosin levels 2

    Serum asprosin levels after 12-16 weeks from initial examination

    After 12-16 weeks from first examination

Study Arms (2)

Myoinositol+D-chiroinositol+folic acid group

EXPERIMENTAL

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)

Drug: inofolic combi

Metformin group

EXPERIMENTAL

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

Drug: Glucophage 500Mg Tablet

Interventions

inofolic combiDRUG

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

Also known as: inofolic combi, ITF company
Myoinositol+D-chiroinositol+folic acid group
Glucophage 500Mg TabletDRUG

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

Also known as: glucophage, Merck company
Metformin group

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Polycystic ovary syndrome patients between 18-40 ages

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Near East University Faculty of Medicine

Nicosia, 99138, Cyprus

Location

Related Publications (11)

  • 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.

    PMID: 23065822BACKGROUND

  • 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.

    PMID: 12909480BACKGROUND

  • 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.

    PMID: 12093242BACKGROUND

  • 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.

    PMID: 23148192BACKGROUND

  • 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.

    PMID: 19056992BACKGROUND

  • 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.

    PMID: 22786777BACKGROUND

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

    PMID: 21845803BACKGROUND

  • 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.

    PMID: 27882049BACKGROUND

  • 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.

    PMID: 28277112BACKGROUND

  • 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.

    PMID: 30524197BACKGROUND

  • 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.

    PMID: 30325247BACKGROUND

MeSH Terms

Conditions

Insulin ResistancePolycystic Ovary SyndromeArachnodactyly

Interventions

MetforminTablets

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesOvarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System DiseasesLimb Deformities, CongenitalMusculoskeletal AbnormalitiesMusculoskeletal DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic ChemicalsDosage FormsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 3, 2023

First Posted

July 19, 2023

Study Start

September 1, 2021

Primary Completion

September 30, 2022

Study Completion

June 3, 2023

Last Updated

July 19, 2023

Record last verified: 2023-07

Locations

CY(1)