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

Completed

• Conditions: Gestational Diabetes

• Registration Number: NCT03964987
• Lead Sponsor: Materno-Perinatal Hospital of the State of Mexico

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2018-01-01
• Primary Completion: 2018-08-30
• Study Completion: 2018-12-31
• Status Verified: 2019-05
• Study First Submitted: 2019-05-21
• Study First Submitted QC: 2019-05-24
• Last Update Submitted: 2019-05-24
• Study First Posted: 2019-05-28
• Last Update Posted: 2019-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 48

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ARNm expression	Nine months	Expression of the genes PDX-1 and NGN-3

Trial Locations

Locations (1)

Materno-Perinatal Hospital "Mónica Pretelini"; 🇲🇽 Toluca, Mexico