TSHβX1 and D2 THR92ALA in Pregnancy

Pregnancy Related Clinical Trial

Official title:

TSHβX1 Splice Variant Expression and D2 Thr92Ala Polymorphism Analysis in Pregnant Women With Thyroid Diseases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03612908
• Other study ID #: 217B500402016054
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Hyperthyroidism
• Hypothyroidism
• Pregnancy Related

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.

External Links

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