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TSHβX1 and D2 THR92ALA in Pregnancy

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ClinicalTrials.gov Identifier: NCT03612908
Recruitment Status : Completed
First Posted : August 2, 2018
Last Update Posted : August 2, 2018
Sponsor:
Collaborators:
Universidad Autonoma del Estado de Mexico
Ciprés Grupo Médico CGM SC
Information provided by (Responsible Party):
Hugo Mendieta Zeron, Materno-Perinatal Hospital of the State of Mexico

Study Description
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Brief Summary:
Thyroid diseases are pathologies that frequently affect pregnant women causing serious complications. This current research aims to find out whether the expression of TSHβX1 splice variant and D2 Thr92Ala polymorphism in the DIO2 gene are associated with thyroid disease in Mexican pregnant women.

Condition or disease
Pregnancy Related Hypothyroidism Hyperthyroidism

Detailed Description:

Deiodinase 2 (DIO2) is a selenoenzyme responsible for the deiodination of T4 to T3, which makes it crucial for the proper functioning of thyroid hormones. Polymorphisms of DIO2 alters the enzymatic function. In addition, the Ala92Ala genotype was reported to be related with a reduction in the placental activity of D2, which could worsen gestational complications.

In the other hand, the TSHβ gene (NC_000001.11) located on chromosome 1 at position 38p12, codes for the beta unit of the thyroid stimulating hormone (TSH). It is admitted that genetic variants can show a different spectrum of actions.

This was a clinical, comparative, prospective and transversal study. Pregnant women aged 18-44 years old, were invited to identify it they had a DIO2 polymorphism or the TSHβX1 splice variant.

Study Design
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Study Type : Observational
Actual Enrollment : 96 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: TSHβX1 Splice Variant Expression and D2 Thr92Ala Polymorphism Analysis in Pregnant Women With Thyroid Diseases
Actual Study Start Date : September 1, 2016
Actual Primary Completion Date : December 15, 2017
Actual Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Normothyroid pregnant women
Healthy pregnant women with the TSH serum values within the recommended ranged per trimester of pregnancy.
Patients with a thyroid disease
Patients with a thyroid disease named hypothyroidism or hyperthyroidism.


Outcome Measures
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Primary Outcome Measures :
  1. TSHβX1 splice variant expression. [ Time Frame: Baseline. ]
    Frequency of positive cases for the TSHβX1 splice variant identified by real-time polymerase change reaction.


Secondary Outcome Measures :
  1. D2 Thr92Ala polymorphism. [ Time Frame: Baseline. ]
    Allele frequency identification of the D2 Thr92Ala polymorphism by genotyping method.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Pregnant women attended at the "Mónica Pretelini Sáenz" Maternal-Perinatal Hospital are mainly of low socioeconomical status.
Criteria

Inclusion Criteria:

  • Pregnant women attended at the "Mónica Pretelini Sáenz" Maternal-Perinatal Hospital (HMPMPS), Health Institute of the State of Mexico (ISEM), Toluca, Mexico.

Exclusion Criteria:

  • Patients with chronic diseases other than hyper or hypothyroidism.
  • Patients that required attention in the obstetric intensive care unit.
Contacts and Locations
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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): NCT03612908


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
Ciprés Grupo Médico CGM SC
Investigators
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Principal Investigator: Mendieta Zerón Hospital Materno-Perinatal "Mónica Pretelini Sáenz".
More Information
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Additional Information:

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: NCT03612908    
Other Study ID Numbers: 217B500402016054
First Posted: August 2, 2018    Key Record Dates
Last Update Posted: August 2, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The information will be available for academic journals if needed.

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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:
Hyperthyroidism
Polymorphism
TSHβX1
D2 THR92ALA
Hypothyroidism
Additional relevant MeSH terms:
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Hypothyroidism
Hyperthyroidism
Thyroid Diseases
Endocrine System Diseases