drugset / Trial / NCT05943158
Myoinositol Effect on Asprosin Levels
RandomizedParallel-groupSingle-blindTreatment
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.
Timeline
- Start
- 2021-06-01
- Primary completion
- 2022-06-30
- Completion
- 2023-06-15
Publications
- Background Romere C, Duerrschmid C, Bournat J, Constable P, Jain M, Xia F, Saha PK, Del Solar M, Zhu B, York B, Sarkar P, Rendon DA, Gaber MW, LeMaire SA, Coselli JS, Milewicz DM, Sutton VR, Butte NF, Moore DD, Chopra AR. Asprosin, a Fasting-Induced Glucogenic Protein Hormone. Cell. 2016 Apr 21;165(3):566-79. doi: 10.1016/j.cell.2016.02.063. Epub 2016 Apr 14.
- 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.
- 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.
- 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.
- Background Metzger BE, Buchanan TA, Coustan DR, de Leiva A, Dunger DB, Hadden DR, Hod M, Kitzmiller JL, Kjos SL, Oats JN, Pettitt DJ, Sacks DA, Zoupas C. Summary and recommendations of the Fifth International Workshop-Conference on Gestational Diabetes Mellitus. Diabetes Care. 2007 Jul;30 Suppl 2:S251-60. doi: 10.2337/dc07-s225. No abstract available.
- 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.
- Background 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.
- Background 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Inositol | Small molecule | 2 g | — |
| Background | folic acid | Other / unclassified | 200 ug | — |
| Background | folic acid | Other / unclassified | 400 ug | — |