TSHβX1 and D2 THR92ALA in Pregnancy

• ClinicalTrials.gov Identifier: NCT03612908
• Recruitment Status: Completed
• First Posted: August 2, 2018
• Last Update Posted: August 2, 2018
• Sponsor: Materno-Perinatal Hospital of the State of Mexico
• 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

Tracking Information

• First Submitted Date: July 20, 2018
• First Posted Date: August 2, 2018
• Last Update Posted Date: August 2, 2018
• Actual Study Start Date: September 1, 2016
• Actual Primary Completion Date: December 15, 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 1, 2018)

TSHβX1 splice variant expression. [ Time Frame: Baseline. ]

Frequency of positive cases for the TSHβX1 splice variant identified by real-time polymerase change reaction.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: August 1, 2018)

D2 Thr92Ala polymorphism. [ Time Frame: Baseline. ]

Allele frequency identification of the D2 Thr92Ala polymorphism by genotyping method.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: TSHβX1 and D2 THR92ALA in Pregnancy
• Official Title: TSHβX1 Splice Variant Expression and D2 Thr92Ala Polymorphism Analysis in Pregnant Women With Thyroid Diseases
• 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.

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 Type: Observational
• Study Design: Observational Model: Case-Control; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Pregnant women attended at the "Mónica Pretelini Sáenz" Maternal-Perinatal Hospital are mainly of low socioeconomical status.

Condition

• Pregnancy Related
• Hypothyroidism
• Hyperthyroidism

• Intervention: Not Provided

Study Groups/Cohorts

• 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.

Publications *

• 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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 1, 2018): 96
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: June 30, 2018
• Actual Primary Completion Date: December 15, 2017 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years to 44 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Mexico

Administrative Information

• NCT Number: NCT03612908
• Other Study ID Numbers: 217B500402016054
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No
• Plan Description: The information will be available for academic journals if needed.

• Responsible Party: Hugo Mendieta Zeron, Materno-Perinatal Hospital of the State of Mexico
• Study Sponsor: Materno-Perinatal Hospital of the State of Mexico

Collaborators

• Universidad Autonoma del Estado de Mexico
• Ciprés Grupo Médico CGM SC

Investigators

• Principal Investigator: Mendieta Zerón; Hospital Materno-Perinatal "Mónica Pretelini Sáenz".

• PRS Account: Materno-Perinatal Hospital of the State of Mexico
• Verification Date: July 2018