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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

Tracking Information
First Submitted Date May 21, 2019
First Posted Date May 28, 2019
Last Update Posted Date May 28, 2019
Actual Study Start Date January 1, 2018
Actual Primary Completion Date August 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 24, 2019)
ARNm expression [ Time Frame: Nine months ]
Expression of the genes PDX-1 and NGN-3
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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 Type Observational [Patient Registry]
Study Design Observational Model: Case-Crossover
Time Perspective: Prospective
Target Follow-Up Duration 9 Months
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Pregnant women attended in the Maternal-Fetal Medicine Service of the HMPMP.
Condition Gestational Diabetes
Intervention Not Provided
Study Groups/Cohorts
  • Control group
    Women with normoevolutionary gestation.
  • Problem group
    Patients with GDM.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 24, 2019)
48
Original Actual Enrollment Same as current
Actual Study Completion Date December 31, 2018
Actual Primary Completion Date August 30, 2018   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Pregnant women
Ages 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Mexico
Removed Location Countries  
 
Administrative Information
NCT Number NCT03964987
Other Study ID Numbers 2016-09-481
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Plan Description: Information will be available upon request.
Responsible Party Hugo Mendieta Zeron, Materno-Perinatal Hospital of the State of Mexico
Study Sponsor Materno-Perinatal Hospital of the State of Mexico
Collaborators Universidad Autonoma del Estado de Mexico
Investigators
Principal Investigator: Hugo Mendieta Zerón, PhD. Maternal-Perinatal Hospital "Mónica Pretelini Sáenz"
PRS Account Materno-Perinatal Hospital of the State of Mexico
Verification Date May 2019