Fibroblast Growth Factors 19 and 21 in Gestational Diabetes Mellitus

NCT01858597 | Completed Results DMC

• 1 other identifier: 5010dong
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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 βKlotho(KLB) 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 FGF19/FGF21 signaling pathway had differential expression in placenta from GDM and normal glucose tolerance pregnancy. Those led us to hypothesize that FGF19/FGF21 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 FGF19/FGF21 signaling pathway are altered and associated with insulin resistance, glucose intolerance, dyslipidemia and adverse pregnancy outcomes. Thus we will evaluate the regulating action of FGF19/FGF21 on gestational insulin resistance. The aim of this study is to elucidate the role of FGF19/FGF21 in insulin resistance and metabolic disorder in GDM.

Conditions

Gestational Diabetes Mellitus

Keywords

GDM, FGF

Outcome Measures

Primary Outcomes (1)

• The Concentration of Serum FGF19

  in fasting state during 24-28 gestational weeks

Secondary Outcomes (1)

• Expression of FGF19 in Term Placenta

  term delivery (when participants come back to hospital to give birth during 37-41 gestational weeks)

Study Arms (2)

gestational diabetes mellitus

OTHER

Those women (subjects) with gestational diabetes mellitus

Diagnostic Test: biachemical detection

control

OTHER

Those healthy pregnant women

Diagnostic Test: biachemical detection

Interventions

biachemical detection DIAGNOSTIC_TEST

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 FGF19/FGF21 and their co-receptor βKlotho（KLB）in 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.

control; gestational diabetes mellitus

Eligibility Criteria

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

You may qualify if:

• Women with singleton pregnancy;
• Regular antenatal examination from the first trimester;
• Give birth in the university hospital (The 1st affiliated hospital of Sun Yat-sen University)

You may not qualify if:

• Younger than 18 years old;
• Older than 40 years old;
• Multiple pregnancy;
• Diagnosed DM before pregnancy;
• Complicated with other diseases such as hypertension, eclampsia, thyroid diseases, etc.;
• Taking any drug that affect glucose and lipid metabolism and insulin sensitivity.

Sponsors & Collaborators

• First Affiliated Hospital, Sun Yat-Sen University: lead

Study Sites (1)

Obstetrics and Gynechology Department of the 1st affiliated hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

Location

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: The first Affiliated Hospital of Sun-Yat Sen University

zsyyyb@mail.sysu.edu.cn

86-020-28823388

Study Officials

• Zilian Wang, M.D., PhD

  Obstetrics and Gynechology Department of the 1st affiliated hospital of SYSU

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: May 16, 2013
• First Posted: May 21, 2013
• Study Start: March 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2016
• Last Updated: May 30, 2023
• Results First Posted: May 30, 2023

Record last verified: 2022-07

Locations

CN (1)