Pancreatic Duodenal Homeobox Factor-1 (PDX-1) and Neurogenin-3 (NGN-3) in Gestational Diabetes

Gestational Diabetes Clinical Trial

Official title:

PDX-1 and NGN-3 Expression in Gestational Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03964987
• Other study ID #: 2016-09-481
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: December 31, 2018

Study information

• Verified date: May 2019
• Source: Materno-Perinatal Hospital of the State of Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Introduction: Depletion of the ability of the cells ß to secrete the amount of insulin required by pregnancy, increasing the risk of develop Gestational Diabetes Mellitus (GDM). The aim was to contrast the messenger RNA (mRNA) expression of the pancreatic duodenal homeobox factor-1 (PDX-1) and Neurogenin-3 (Ngn-3) in peripheral blood of pregnant women with GDM versus women with normal pregnancies.

Material and methods: This was a prospective, clinical and cross-sectional study, conforming two groups of pregnant women: a) patients with a healthy gestation and b) patients with GDM. Besides anthropometry and routine laboratorial test, real-time polymerase chain reaction (Real-Time PCR), was used to quantify the expression of PDX-1 and NGN-3.

Description:

Pregnant women attended in the Maternal-Fetal Medicine Service of the "Mónica Pretelini Sáenz" Maternal-Perinatal Hospital, were invited to participate. Those with autoimmune diseases, heart disease, nephropathy, liver disease or any other chronic condition were excluded and those with incomplete clinical files were discarded from the final analysis. Two groups were integrated: a) patients with a healthy gestation and b) patients with GDM.

From all patients the next information was captured in an excell sheet: weight, height, Body Mass Index, blood pressure, albumin, creatinine, electrolytes, glucose, total cholesterol, triglycerides, transaminases and relative expression of PDX-1 and NGN-3.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 31, 2018
• Est. primary completion date: August 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Pregnant women older than 18 years old.

Exclusion Criteria:

• Those with autoimmune diseases, heart disease, nephropathy, liver disease or any other chronic condition.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes

Locations

Country	Name	City	State
Mexico	Materno-Perinatal Hospital "Mónica Pretelini"	Toluca

Sponsors (2)

Lead Sponsor	Collaborator
Materno-Perinatal Hospital of the State of Mexico	Universidad Autonoma del Estado de Mexico

Country where clinical trial is conducted

Mexico, 

References & Publications (4)

Gu G, Dubauskaite J, Melton DA. Direct evidence for the pancreatic lineage: NGN3+ cells are islet progenitors and are distinct from duct progenitors. Development. 2002 May;129(10):2447-57. — View Citation

Plows JF, Stanley JL, Baker PN, Reynolds CM, Vickers MH. The Pathophysiology of Gestational Diabetes Mellitus. Int J Mol Sci. 2018 Oct 26;19(11). pii: E3342. doi: 10.3390/ijms19113342. Review. — View Citation

Sandikci M, Karagenc L, Yildiz M. Changes on the Pancreas in Experimental Diabetes and the Effect of Lycopene on These Changes: Pdx-1, Ngn-3, and Nestin Expressions. Anat Rec (Hoboken). 2017 Dec;300(12):2200-2207. doi: 10.1002/ar.23687. Epub 2017 Sep 26. — View Citation

Wang L, Fan H, Zhou L, Wu Y, Lu H, Luo J. Altered expression of PGC-1a and PDX1 and their methylation status are associated with fetal glucose metabolism in gestational diabetes mellitus. Biochem Biophys Res Commun. 2018 Jun 18;501(1):300-306. doi: 10.101 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ARNm expression	Expression of the genes PDX-1 and NGN-3	Nine months