TSHβX1 and D2 THR92ALA in Pregnancy

NCT ID: NCT03612908

Last Updated: 2018-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

96 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-09-01

Study Completion Date

2018-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pregnancy Related Hypothyroidism Hyperthyroidism

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Normothyroid pregnant women

Healthy pregnant women with the TSH serum values within the recommended ranged per trimester of pregnancy.

No interventions assigned to this group

Patients with a thyroid disease

Patients with a thyroid disease named hypothyroidism or hyperthyroidism.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

44 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Universidad Autonoma del Estado de Mexico

OTHER

Sponsor Role collaborator

Ciprés Grupo Médico CGM SC

OTHER

Sponsor Role collaborator

Materno-Perinatal Hospital of the State of Mexico

OTHER

Sponsor Role lead

Responsible Party

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Hugo Mendieta Zeron

Chief of the Research Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mendieta Zerón

Role: PRINCIPAL_INVESTIGATOR

Hospital Materno-Perinatal "Mónica Pretelini Sáenz".

Locations

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Materno-Perinatal Hospital "Mónica Pretelini"

Toluca, , Mexico

Site Status

Countries

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Mexico

References

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Wouters HJ, van Loon HC, van der Klauw MM, Elderson MF, Slagter SN, Kobold AM, Kema IP, Links TP, van Vliet-Ostaptchouk JV, Wolffenbuttel BH. No Effect of the Thr92Ala Polymorphism of Deiodinase-2 on Thyroid Hormone Parameters, Health-Related Quality of Life, and Cognitive Functioning in a Large Population-Based Cohort Study. Thyroid. 2017 Feb;27(2):147-155. doi: 10.1089/thy.2016.0199. Epub 2016 Dec 15.

Reference Type BACKGROUND
PMID: 27786042 (View on PubMed)

Leung AM. Thyroid function in pregnancy. J Trace Elem Med Biol. 2012 Jun;26(2-3):137-40. doi: 10.1016/j.jtemb.2012.03.004. Epub 2012 Jun 2.

Reference Type BACKGROUND
PMID: 22658718 (View on PubMed)

Related Links

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http://www.ncbi.nlm.nih.gov/nuccore/XM_011542065.2

PREDICTED: Homo sapiens thyroid stimulating hormone beta (TSHB), transcript variant X1.

Other Identifiers

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217B500402016054

Identifier Type: -

Identifier Source: org_study_id

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