Myoinositol Effect on Asprosin Levels

NCT05943158 | Completed

• 1 other identifier: Pregnancy ASP
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Asprosin is aa adipokine associated with glucose and insulin metabolism. Insulin and glucose metabolism change during pregnancy and studies examining asprosin levels during pregnancy are increasing rapidly. Considering the beneficial effects of myo-inositol to support the physiological pregnancy, recovering and pre-venting adverse maternal and fetal outcomes, we aimed to evaluate the effects of its supplementation on serum asprosin levels in pregnant women.

Conditions

Pregnancy Related

Keywords

pregnancy; myoinositol; asprosin

Outcome Measures

Primary Outcomes (2)

• Serum asprosin levels

  First measurement of serum asprosin level at initial examination

  between 5-8 weeks of gestation

• Serum asprosin levels

  Serum asprosin measurement at the time of oral glucose tolerance test

  between 24-28 weeks of gestation which the oral glucose tolerance test is done

Study Arms (2)

Myoinositol+folic acid group

EXPERIMENTAL

This group is given myoinositol+folic acid (inofolic, ITF company, Italy) (myoinositol 4 gram+folic acid 400 micrograms)

Drug: myoinositol and folic acid

Only folic acid group

EXPERIMENTAL

This group is given only folic acid once a day (400 micrograms a day)

Drug: folic acid

Interventions

myoinositol and folic acid DRUG

The pregnant women were given myoinositol+folic acid starting from initial examination of pregnancy until 24-28 weeks of gestation (time of oral glucose tolerance test)

Also known as: inofolic, ITF company

Myoinositol+folic acid group

folic acid DRUG

The pregnant women were given only folic acid starting from initial examination of pregnancy until 24-28 weeks of gestation (time of oral glucose tolerance test)

Also known as: folidoce, ITF company

Only folic acid group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy pregnant women between 18-40 ages

You may not qualify if:

• chronic hypertension,
• pre-pregnancy diabetes or a history of GDM in a previous pregnancy,
• multiple pregnancy,
• history of pregnancy-induced hypertension,
• addiction such as smoking or alcohol,
• thyroid or other endocrine diseases

Sponsors & Collaborators

• Near East University, Turkey: lead

Study Sites (1)

Near East University Faculty of Medicine

Nicosia, 99138, Cyprus

Location

Related Publications (17)

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  PMID: 27087445 BACKGROUND

• Zhang L, Chen C, Zhou N, Fu Y, Cheng X. Circulating asprosin concentrations are increased in type 2 diabetes mellitus and independently associated with fasting glucose and triglyceride. Clin Chim Acta. 2019 Feb;489:183-188. doi: 10.1016/j.cca.2017.10.034. Epub 2017 Nov 3.

  PMID: 29104036 BACKGROUND

• Wang Y, Qu H, Xiong X, Qiu Y, Liao Y, Chen Y, Zheng Y, Zheng H. Plasma Asprosin Concentrations Are Increased in Individuals with Glucose Dysregulation and Correlated with Insulin Resistance and First-Phase Insulin Secretion. Mediators Inflamm. 2018 Mar 20;2018:9471583. doi: 10.1155/2018/9471583. eCollection 2018.

  PMID: 29743813 BACKGROUND

• Hong T, Li JY, Wang YD, Qi XY, Liao ZZ, Bhadel P, Ran L, Yang J, Yan B, Liu JH, Xiao XH. High Serum Asprosin Levels Are Associated with Presence of Metabolic Syndrome. Int J Endocrinol. 2021 Mar 2;2021:6622129. doi: 10.1155/2021/6622129. eCollection 2021.

  PMID: 33747078 BACKGROUND

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  PMID: 17596481 BACKGROUND

• Kleiblova P, Dostalova I, Bartlova M, Lacinova Z, Ticha I, Krejci V, Springer D, Kleibl Z, Haluzik M. Expression of adipokines and estrogen receptors in adipose tissue and placenta of patients with gestational diabetes mellitus. Mol Cell Endocrinol. 2010 Jan 15;314(1):150-6. doi: 10.1016/j.mce.2009.08.002. Epub 2009 Aug 12.

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• American Diabetes Association. Diagnosis and classification of diabetes mellitus. Diabetes Care. 2014 Jan;37 Suppl 1:S81-90. doi: 10.2337/dc14-S081. No abstract available.

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• Coustan DR, Lowe LP, Metzger BE, Dyer AR; International Association of Diabetes and Pregnancy Study Groups. The Hyperglycemia and Adverse Pregnancy Outcome (HAPO) study: paving the way for new diagnostic criteria for gestational diabetes mellitus. Am J Obstet Gynecol. 2010 Jun;202(6):654.e1-6. doi: 10.1016/j.ajog.2010.04.006.

  PMID: 20510967 BACKGROUND

• Mulla WR, Henry TQ, Homko CJ. Gestational diabetes screening after HAPO: has anything changed? Curr Diab Rep. 2010 Jun;10(3):224-8. doi: 10.1007/s11892-010-0109-3.

  PMID: 20425586 BACKGROUND

• Hoffmann T, Morcos YAT, Janoschek R, Turnwald EM, Gerken A, Muller A, Sengle G, Dotsch J, Appel S, Hucklenbruch-Rother E. Correlation of metabolic characteristics with maternal, fetal and placental asprosin in human pregnancy. Endocr Connect. 2022 Mar 14;11(3):e220069. doi: 10.1530/EC-22-0069.

  PMID: 35148275 BACKGROUND

• Baykus Y, Yavuzkir S, Ustebay S, Ugur K, Deniz R, Aydin S. Asprosin in umbilical cord of newborns and maternal blood of gestational diabetes, preeclampsia, severe preeclampsia, intrauterine growth retardation and macrosemic fetus. Peptides. 2019 Oct;120:170132. doi: 10.1016/j.peptides.2019.170132. Epub 2019 Aug 7.

  PMID: 31400492 BACKGROUND

• Croze ML, Soulage CO. Potential role and therapeutic interests of myo-inositol in metabolic diseases. Biochimie. 2013 Oct;95(10):1811-27. doi: 10.1016/j.biochi.2013.05.011. Epub 2013 Jun 10.

  PMID: 23764390 BACKGROUND

• Unfer V, Carlomagno G, Dante G, Facchinetti F. Effects of myo-inositol in women with PCOS: a systematic review of randomized controlled trials. Gynecol Endocrinol. 2012 Jul;28(7):509-15. doi: 10.3109/09513590.2011.650660. Epub 2012 Feb 1.

  PMID: 22296306 BACKGROUND

• Facchinetti F, Cavalli P, Copp AJ, D'Anna R, Kandaraki E, Greene NDE, Unfer V; Experts Group on Inositol in Basic and Clinical Research. An update on the use of inositols in preventing gestational diabetes mellitus (GDM) and neural tube defects (NTDs). Expert Opin Drug Metab Toxicol. 2020 Dec;16(12):1187-1198. doi: 10.1080/17425255.2020.1828344. Epub 2020 Nov 10.

  PMID: 32966143 BACKGROUND

• Motuhifonua SK, Lin L, Alsweiler J, Crawford TJ, Crowther CA. Antenatal dietary supplementation with myo-inositol for preventing gestational diabetes. Cochrane Database Syst Rev. 2023 Feb 15;2(2):CD011507. doi: 10.1002/14651858.CD011507.pub3.

  PMID: 36790138 BACKGROUND

• Facchinetti F, Appetecchia M, Aragona C, Bevilacqua A, Bezerra Espinola MS, Bizzarri M, D'Anna R, Dewailly D, Diamanti-Kandarakis E, Hernandez Marin I, Kamenov ZA, Kandaraki E, Lagana AS, Monastra G, Montanino Oliva M, Nestler JE, Orio F, Ozay AC, Papalou O, Pkhaladze L, Porcaro G, Prapas N, Soulage CO, Stringaro A, Wdowiak A, Unfer V. Experts' opinion on inositols in treating polycystic ovary syndrome and non-insulin dependent diabetes mellitus: a further help for human reproduction and beyond. Expert Opin Drug Metab Toxicol. 2020 Mar;16(3):255-274. doi: 10.1080/17425255.2020.1737675. Epub 2020 Mar 19.

  PMID: 32129111 BACKGROUND

• Ozay AC, Ozay OE, Edebal OH, Ozay Y, Montanino Oliva M, Dinicola S, Unfer V. Effect of Myo-Inositol Treatment on Serum Asprosin Levels of Pregnant Women: A Prospective Randomized Controlled Pilot Study. J Pregnancy. 2025 Dec 28;2025:8816154. doi: 10.1155/jp/8816154. eCollection 2025.

  PMID: 41497562 DERIVED

MeSH Terms

Conditions

Arachnodactyly

Interventions

Inositol; Folic Acid

Condition Hierarchy (Ancestors)

Limb Deformities, Congenital; Musculoskeletal Abnormalities; Musculoskeletal Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

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: June 20, 2023
• First Posted: July 13, 2023
• Study Start: June 1, 2021
• Primary Completion: June 30, 2022
• Study Completion: June 15, 2023
• Last Updated: July 13, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR

Locations

CY (1)