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

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ClinicalTrials.gov Identifier: NCT03964987
Recruitment Status : Completed
First Posted : May 28, 2019
Last Update Posted : May 28, 2019
Sponsor:
Collaborator:
Universidad Autonoma del Estado de Mexico
Information provided by (Responsible Party):
Hugo Mendieta Zeron, 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.


Condition or disease
Gestational Diabetes

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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 48 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Target Follow-Up Duration: 9 Months
Official Title: PDX-1 and NGN-3 Expression in Gestational Diabetes
Actual Study Start Date : January 1, 2018
Actual Primary Completion Date : August 30, 2018
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


Group/Cohort
Control group
Women with normoevolutionary gestation.
Problem group
Patients with GDM.



Primary Outcome Measures :
  1. ARNm expression [ Time Frame: Nine months ]
    Expression of the genes PDX-1 and NGN-3



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnant women
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Pregnant women attended in the Maternal-Fetal Medicine Service of the HMPMP.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03964987


Locations
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Mexico
Materno-Perinatal Hospital "Mónica Pretelini"
Toluca, Mexico, 50130
Sponsors and Collaborators
Materno-Perinatal Hospital of the State of Mexico
Universidad Autonoma del Estado de Mexico
Investigators
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Principal Investigator: Hugo Mendieta Zerón, PhD. Maternal-Perinatal Hospital "Mónica Pretelini Sáenz"
Publications of Results:
Other Publications:
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Responsible Party: Hugo Mendieta Zeron, Chief of the Research Department, Materno-Perinatal Hospital of the State of Mexico
ClinicalTrials.gov Identifier: NCT03964987    
Other Study ID Numbers: 2016-09-481
First Posted: May 28, 2019    Key Record Dates
Last Update Posted: May 28, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Information will be available upon request.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hugo Mendieta Zeron, Materno-Perinatal Hospital of the State of Mexico:
PDX-1
NGN-3
Glucose
Additional relevant MeSH terms:
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Diabetes, Gestational
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications