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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03612908
Other study ID # 217B500402016054
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2016
Est. completion date June 30, 2018

Study information

Verified date July 2018
Source Materno-Perinatal Hospital of the State of Mexico
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 96
Est. completion date June 30, 2018
Est. primary completion date December 15, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 44 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Mexico Materno-Perinatal Hospital "Mónica Pretelini" Toluca

Sponsors (3)

Lead Sponsor Collaborator
Materno-Perinatal Hospital of the State of Mexico Ciprés Grupo Médico CGM SC, Universidad Autonoma del Estado de Mexico

Country where clinical trial is conducted

Mexico, 

References & Publications (2)

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. Review. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary TSHßX1 splice variant expression. Frequency of positive cases for the TSHßX1 splice variant identified by real-time polymerase change reaction. Baseline.
Secondary D2 Thr92Ala polymorphism. Allele frequency identification of the D2 Thr92Ala polymorphism by genotyping method. Baseline.
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