Ignite Creation Date:
2024-05-06 @ 1:37 AM
Last Modification Date:
2024-10-26 @ 11:07 AM
Study NCT ID:
NCT01858597
Status:
COMPLETED
Last Update Posted:
2023-05-30
First Post:
2013-05-16
Brief Title:
Fibroblast Growth Factors 19 and 21 in Gestational Diabetes Mellitus
Sponsor:
First Affiliated Hospital Sun Yat-Sen University
Organization:
First Affiliated Hospital Sun Yat-Sen University
Study Overview
Official Title:
Endocrine Fibroblast Growth Factor 19 and 21 Regulate the Insulin Resistance State in Gestational Diabetes Mellitus
Status:
COMPLETED
Status Verified Date:
2022-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Gestational diabetes mellitus GDM is the most common complication in pregnancy Both mother and offspring have a significantly increased future risk for metabolic and cardiovascular disease as a consequence of GDM Pathological insulin resistance and the pancreatic β-cell dysfunction may contribute to the development and adverse outcomes of GDM
Recently fibroblast growth factor 19 FGF19 and FGF21 have emerged as key endocrine regulators of glucose lipid and energy metabolism Both factors activate FGFRs in the context of co-receptor βKlothoKLB expression After that both proteins alter ERK phosphorylation and stimulate glucose uptake Furthermore these two factors ameliorate insulin resistance through various ways including up-regulating insulin mRNA IRS-1 GLUT-1 expressions down-regulating GH-IGF-1 levels in different tissues and blood circulation and also improving dyslipidemia
Our previous studies showed that several factors which involved in insulin resistance and FGF19FGF21 signaling pathway had differential expression in placenta from GDM and normal glucose tolerance pregnancy Those led us to hypothesize that FGF19FGF21 signaling pathway could play an important role in the pathogenesis and development of insulin resistance state in GDM
In the present study we will further investigate whether maternal and neonatal FGF19FGF21 signaling pathway are altered and associated with insulin resistance glucose intolerance dyslipidemia and adverse pregnancy outcomes Thus we will evaluate the regulating action of FGF19FGF21 on gestational insulin resistance
The aim of this study is to elucidate the role of FGF19FGF21 in insulin resistance and metabolic disorder in GDM
Recently fibroblast growth factor 19 FGF19 and FGF21 have emerged as key endocrine regulators of glucose lipid and energy metabolism Both factors activate FGFRs in the context of co-receptor βKlothoKLB expression After that both proteins alter ERK phosphorylation and stimulate glucose uptake Furthermore these two factors ameliorate insulin resistance through various ways including up-regulating insulin mRNA IRS-1 GLUT-1 expressions down-regulating GH-IGF-1 levels in different tissues and blood circulation and also improving dyslipidemia
Our previous studies showed that several factors which involved in insulin resistance and FGF19FGF21 signaling pathway had differential expression in placenta from GDM and normal glucose tolerance pregnancy Those led us to hypothesize that FGF19FGF21 signaling pathway could play an important role in the pathogenesis and development of insulin resistance state in GDM
In the present study we will further investigate whether maternal and neonatal FGF19FGF21 signaling pathway are altered and associated with insulin resistance glucose intolerance dyslipidemia and adverse pregnancy outcomes Thus we will evaluate the regulating action of FGF19FGF21 on gestational insulin resistance
The aim of this study is to elucidate the role of FGF19FGF21 in insulin resistance and metabolic disorder in GDM
Detailed Description:
First30 pregnant women with GDM and 60 pregnant control women with normal glucose tolerance NGT matched for maternal and gestational age were enrolled in the study All the subjects underwent antepartum screening in the First Affiliated Hospital of Sun Yat-sen University Blood samples were obtained after overnight fasting at the time of oral glucose tolerance test OGTT Serum FGF19 and FGF21 levels were determined by enzyme-linked immunosorbent assay ELISA and were correlated with anthropometric metabolic and endocrine parameters Homeostasis model assessment HOMA-IR index was calculated and analysed
Second samples for measurement were obtained from 30 women with GDM and 35 healthy pregnant controls undergoing caesarean sections at term mRNA and protein expression levels of FGF19FGF21 and their co-receptor βKlothoKLBin placenta rectus muscle and subcutaneous fat tissues were investigated with real-time quantitative polymerase chain reaction qRT-PCR western-blot and immunohistochemistry IHC respectively Clinical data were collected and analysed
Data were analyzed by SPSS 200 database The results were expressed as mean standard deviations or median with interquartile range Differences between groups were assessed by Students unpaired t test Mann-Whitney U test or Chi-square test as appropriate Correlation analysis was performed using the Spearman rank correlation method To identify independent relationships and adjust the effects of covariates multiple linear regression analyses were performed P values of 005 were considered significant
Second samples for measurement were obtained from 30 women with GDM and 35 healthy pregnant controls undergoing caesarean sections at term mRNA and protein expression levels of FGF19FGF21 and their co-receptor βKlothoKLBin placenta rectus muscle and subcutaneous fat tissues were investigated with real-time quantitative polymerase chain reaction qRT-PCR western-blot and immunohistochemistry IHC respectively Clinical data were collected and analysed
Data were analyzed by SPSS 200 database The results were expressed as mean standard deviations or median with interquartile range Differences between groups were assessed by Students unpaired t test Mann-Whitney U test or Chi-square test as appropriate Correlation analysis was performed using the Spearman rank correlation method To identify independent relationships and adjust the effects of covariates multiple linear regression analyses were performed P values of 005 were considered significant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None