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AzTrials

PCOSNCT05951309

Myoinositol Treatment and Asprosin Levels in PCOS

A study testing inofolic combi and Glucophage 500Mg Tablet in people with PCOS and Insulin Resistance, run by Near East University, Turkey at 1 site in Cyprus.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 40 years, women only
Conditions the study is for
PCOS, Insulin Resistance
What is being tested?
inofolic combi and Glucophage 500Mg Tablet
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteCyprus
Study dates
1 Sep 2021to 3 Jun 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Polycystic ovary syndrome patients between 18-40 ages

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Cyprus1 site

  • Near East University Faculty of Medicine

    Nicosia, 99138

Other trials in Cyprus

About this study

Official title: Effect of Myoinositol on Serum Asprosin Levels in PCOS Patients

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.

Read the 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.

Being tested
inofolic combi, Glucophage 500Mg Tablet
Keywords
Polycystic ovary syndrome, Myoinositol, Metformin, Insulin resistance, Asprosin
Medical subject headings
Insulin Resistance, Polycystic Ovary Syndrome, Arachnodactyly

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • inofolic combiDrug

    Also called inofolic combi, ITF company

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

  • Glucophage 500Mg TabletDrug

    Also called glucophage, Merck company

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

Study groups in NCT05951309
Study groupRoleWhat they receive
Myoinositol+D-chiroinositol+folic acid groupExperimentalThis 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)
Receives: Drug: inofolic combi
Metformin groupExperimentalThis group is given metformin 500 miligram three times a day (glucophage 500mg, Merck company, Turkey) (total dose of metformin 1500 miligram a day)
Receives: Drug: Glucophage 500Mg Tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Serum asprosin levels 1

    First measurement of serum asprosin level at initial examination

    Measured: Second or third day of menstruation

  2. Serum asprosin levels 2

    Serum asprosin levels after 12-16 weeks from initial examination

    Measured: After 12-16 weeks from first examination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2023
  2. Study start1 Sep 2021
  3. Primary completion30 Sep 2022
  4. Study completion3 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05951309
Sponsor's protocol ID
Asprosin-PCOS
Status last verified
Jul 2023
First submitted
3 Jul 2023
Last updated
19 Jul 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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.

    PubMed 23065822

  • 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.

    PubMed 12909480

  • 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.

    PubMed 12093242

  • 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.

    PubMed 23148192

  • 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.

    PubMed 19056992

  • 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.

    PubMed 22786777

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

    PubMed 21845803

  • 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.

    PubMed 27882049

  • 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.

    PubMed 28277112

  • 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.

    PubMed 30524197

  • 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.

    PubMed 30325247

Questions about this trial

What is this clinical trial studying?

A study testing inofolic combi and Glucophage 500Mg Tablet in people with PCOS and Insulin Resistance, run by Near East University, Turkey at 1 site in Cyprus.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Cyprus. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Serum asprosin levels 1 (time frame: Second or third day of menstruation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05951309, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2023.

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