Clinical trial NCT03964987: Pancreatic Duodenal Homeobox Factor-1 (PDX-1) and Neurogenin-3 (NGN-3) in Gestational Diabetes
Official title: PDX-1 and NGN-3 Expression in Gestational Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gestational Diabetes
Keywords: PDX-1
NGN-3
Glucose
Lead sponsor: Materno-Perinatal Hospital of the State of Mexico
Sponsor class: OTHER
Collaborators: name: Universidad Autonoma del Estado de Mexico
First posted: 2019-05-28
Enrollment: 48
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women attended in the Maternal-Fetal Medicine Service of the HMPMP.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: ARNm expression
timeFrame: Nine months
Secondary outcomes:
Other outcomes:
Locations:
city: Toluca
country: Mexico
facility: Materno-Perinatal Hospital "Mónica Pretelini"
Study officials:
affiliation: Maternal-Perinatal Hospital "Mónica Pretelini Sáenz"
name: Hugo Mendieta Zerón, PhD.
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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. doi: 10.1242/dev.129.10.2447.
citation: Wang L, Fan H, Zhou L, Wu Y, Lu H, Luo J. Altered expression of PGC-1alpha 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: 10.1016/j.bbrc.2018.05.010. Epub 2018 May 7.
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):3342. doi: 10.3390/ijms19113342.