NCT03964987

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 21, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 28, 2019

Completed
Last Updated

May 28, 2019

Status Verified

May 1, 2019

Enrollment Period

8 months

First QC Date

May 21, 2019

Last Update Submit

May 24, 2019

Conditions

Keywords

PDX-1NGN-3Glucose

Outcome Measures

Primary Outcomes (1)

  • ARNm expression

    Expression of the genes PDX-1 and NGN-3

    Nine months

Study Arms (2)

Control group

Women with normoevolutionary gestation.

Problem group

Patients with GDM.

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant women
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pregnant women attended in the Maternal-Fetal Medicine Service of the HMPMP.

You may qualify if:

  • Pregnant women older than 18 years old.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Materno-Perinatal Hospital "Mónica Pretelini"

Toluca, 50130, Mexico

Location

Related Publications (4)

  • 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.

    PMID: 28921917BACKGROUND
  • 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.

    PMID: 11973276BACKGROUND
  • 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.

  • 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.

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Hugo Mendieta Zerón, PhD.

    Maternal-Perinatal Hospital "Mónica Pretelini Sáenz"

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Target Duration
9 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of the Research Department

Study Record Dates

First Submitted

May 21, 2019

First Posted

May 28, 2019

Study Start

January 1, 2018

Primary Completion

August 30, 2018

Study Completion

December 31, 2018

Last Updated

May 28, 2019

Record last verified: 2019-05

Locations