Pregnancy RelatedNCT05943158
Myoinositol Effect on Asprosin Levels
A study testing myoinositol and folic acid and folic acid in people with Pregnancy Related, run by Near East University, Turkey at 1 site in Cyprus.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related
- What is being tested?
- myoinositol and folic acid and folic acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCyprus
- Study dates
- 1 Jun 2021to 15 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy pregnant women between 18-40 ages
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Myoinositol on Serum Asprosin Levels in Pregnant Women
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.
Read the detailed description
Asprosin, which was first mentioned in an article in 2016, is a pluripotent adipokine that is a product of profibrillin and its main source is white adipose tissue. It has been observed that asprosin is associated with glucose metabolism, and its plasma level increases after overnight fasting and decreases after feeding. After the demonstration that asprosin increases glucose secretion from the liver, subsequent studies have determined that its serum levels are increased in type 2 diabetes, human and mouse models with insulin resistance, positively correlates with obesity, and high asprosin levels have been associated with metabolic syndrome.
Pregnancy is known to be a diabetogenic process and insulin resistance is increased during gestation. Also, it is known that there is an increase in the production of adipokines during pregnancy. There are a limited number of studies in pregnancy on asprosin which is known to be produced also from the placenta. Studies examining asprosin in pregnancy in the literature mostly examined the relationship between gestational diabetes (GDM). GDM, which is defined as glucose intolerance with variable severity of hyperglycemia that occurs during pregnancy, is the most common metabolic disorder during pregnancy and its prevalence varies between 5-10% according to the patient population examined and the diagnostic test used. In addition, these patients also have impaired insulin secretion. Recently, it has been shown that asprosin levels are increased in the blood of patients with GDM.
Inositol is a polyol structure molecule belonging to the vitamin B complex, which can be produced in many organs in the body and can also be taken from the outside with food. Myo-inositol (MI) is one of the most important of the 9 inositol stereoisomers, and this molecule has been studied many times in the literature in recent years. In the literature, it is stated that inositol supplementation started in the early weeks of pregnancy prevents GDM onset, especially in women in the risk group for developing GDM like obesity, polycystic ovary syndrome, etc.. MI, which is an intracellular second messenger and has insulin-like effects on glucose metabolism, also reduces insulin resistance.
Based on these data in the literature, it can be thought that altered serum asprosin levels during pregnancy may play a role in the pathogenesis of GDM. In addition, it can be suggested that MI, which have proven effects on glucose metabolism, may have an effect on serum levels of asprosin, which is considered a new insulin resistance marker. In this study, we aimed to examine the effect of the MI on serum asprosin levels of women, which was started in the early stages of pregnancy.
- Conditions
- Pregnancy Related
- Being tested
- myoinositol and folic acid, folic acid
- Keywords
- pregnancy, myoinositol, asprosin
- Medical subject headings
- Arachnodactyly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
myoinositol and folic acidDrug
Also called inofolic, ITF company
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)
folic acidDrug
Also called folidoce, ITF company
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)
| Study group | Role | What they receive |
|---|---|---|
| Myoinositol+folic acid group | Experimental | This group is given myoinositol+folic acid (inofolic, ITF company, Italy) (myoinositol 4 gram+folic acid 400 micrograms) Receives: Drug: myoinositol and folic acid |
| Only folic acid group | Experimental | This group is given only folic acid once a day (400 micrograms a day) Receives: Drug: folic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum asprosin levels
First measurement of serum asprosin level at initial examination
Measured: between 5-8 weeks of gestation
Serum asprosin levels
Serum asprosin measurement at the time of oral glucose tolerance test
Measured: between 24-28 weeks of gestation which the oral glucose tolerance test is done
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2023
- Study start1 Jun 2021
- Primary completion30 Jun 2022
- Study completion15 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Near East University, Turkey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Cenk, Cyprus International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05943158
- Sponsor's protocol ID
- Pregnancy ASP
- Status last verified
- Jul 2023
- First submitted
- 20 Jun 2023
- Last updated
- 13 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 27087445Zhang 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.
PubMed 29104036Wang 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.
PubMed 29743813Hong 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.
PubMed 33747078Metzger 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.
PubMed 17596481Kleiblova 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.
PubMed 19682537American 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.
PubMed 24357215Coustan 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.
PubMed 20510967Mulla 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.
PubMed 20425586Hoffmann 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.
PubMed 35148275Baykus 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.
PubMed 31400492Croze 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.
PubMed 23764390Unfer 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.
PubMed 22296306Facchinetti 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.
PubMed 32966143Motuhifonua 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.
PubMed 36790138
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Myoinositol on Serum Asprosin Levels in Pregnant Women
- ClinicalTrials.gov ID
- NCT05943158
- Acronym / sponsor ID
- Pregnancy ASP
- Conditions
- Pregnancy Related
- Keywords
- pregnancy, myoinositol, asprosin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Near East University, TurkeyUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 15 Jun 2023 (actual)
- First posted
- 13 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Asprosin, which was first mentioned in an article in 2016, is a pluripotent adipokine that is a product of profibrillin and its main source is white adipose tissue. It has been observed that asprosin is associated with glucose metabolism, and its plasma level increases after overnight fasting and decreases after feeding. After the demonstration that asprosin increases glucose secretion from the liver, subsequent studies have determined that its serum levels are increased in type 2 diabetes, human and mouse models with insulin resistance, positively correlates with obesity, and high asprosin levels have been associated with metabolic syndrome.
Pregnancy is known to be a diabetogenic process and insulin resistance is increased during gestation. Also, it is known that there is an increase in the production of adipokines during pregnancy. There are a limited number of studies in pregnancy on asprosin which is known to be produced also from the placenta. Studies examining asprosin in pregnancy in the literature mostly examined the relationship between gestational diabetes (GDM). GDM, which is defined as glucose intolerance with variable severity of hyperglycemia that occurs during pregnancy, is the most common metabolic disorder during pregnancy and its prevalence varies between 5-10% according to the patient population examined and the diagnostic test used. In addition, these patients also have impaired insulin secretion. Recently, it has been shown that asprosin levels are increased in the blood of patients with GDM.
Inositol is a polyol structure molecule belonging to the vitamin B complex, which can be produced in many organs in the body and can also be taken from the outside with food. Myo-inositol (MI) is one of the most important of the 9 inositol stereoisomers, and this molecule has been studied many times in the literature in recent years. In the literature, it is stated that inositol supplementation started in the early weeks of pregnancy prevents GDM onset, especially in women in the risk group for developing GDM like obesity, polycystic ovary syndrome, etc.. MI, which is an intracellular second messenger and has insulin-like effects on glucose metabolism, also reduces insulin resistance.
Based on these data in the literature, it can be thought that altered serum asprosin levels during pregnancy may play a role in the pathogenesis of GDM. In addition, it can be suggested that MI, which have proven effects on glucose metabolism, may have an effect on serum levels of asprosin, which is considered a new insulin resistance marker. In this study, we aimed to examine the effect of the MI on serum asprosin levels of women, which was started in the early stages of pregnancy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Myoinositol+folic acid group | Experimental | Drug: myoinositol and folic acidThis group is given myoinositol+folic acid (inofolic, ITF company, Italy) (myoinositol 4 gram+folic acid 400 micrograms) |
| Only folic acid group | Experimental | Drug: folic acidThis group is given only folic acid once a day (400 micrograms a day) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy pregnant women between 18-40 ages
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| myoinositol and folic acidAlso: inofolic, ITF companyThe 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) | Drug | Myoinositol+folic acid group |
| folic acidAlso: folidoce, ITF companyThe 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) | Drug | Only folic acid group |
Primary outcome
Serum asprosin levels
Time frame: between 5-8 weeks of gestation
First measurement of serum asprosin level at initial examination
Serum asprosin levels
Time frame: between 24-28 weeks of gestation which the oral glucose tolerance test is done
Serum asprosin measurement at the time of oral glucose tolerance test
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2023.
- Background: PubMed 27087445Romere 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: PubMed 29104036Zhang 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: PubMed 29743813Wang 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: PubMed 33747078Hong 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: PubMed 17596481Metzger 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: PubMed 19682537Kleiblova 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: PubMed 24357215American 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: PubMed 20510967Coustan 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: PubMed 20425586Mulla 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: PubMed 35148275Hoffmann 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: PubMed 31400492Baykus 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: PubMed 23764390Croze 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing myoinositol and folic acid and folic acid in people with Pregnancy Related, 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 6 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 13 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 (time frame: between 5-8 weeks of gestation). 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 NCT05943158, which also lists 17 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 13 Jul 2023.