Pregnancy RelatedNCT03612908
TSHβX1 and D2 THR92ALA in Pregnancy
An observational study of Pregnancy Related and Hypothyroidism, run by Materno-Perinatal Hospital of the State of Mexico at 1 site in Mexico.
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. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related, Hypothyroidism, Hyperthyroidism
- How many people
- 96 participants
- Where
- 1 siteMexico
- Study dates
- 1 Sep 2016to 30 Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 44 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant women attended at the "Mónica Pretelini Sáenz" Maternal-Perinatal Hospital are mainly of low socioeconomical status.
Who may be able to join
- Pregnant women attended at the "Mónica Pretelini Sáenz" Maternal-Perinatal Hospital (HMPMPS), Health Institute of the State of Mexico (ISEM), Toluca, Mexico.
Who cannot join
- Patients with chronic diseases other than hyper or hypothyroidism.
- Patients that required attention in the obstetric intensive care unit.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: TSHβX1 Splice Variant Expression and D2 Thr92Ala Polymorphism Analysis in Pregnant Women With Thyroid Diseases
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.
Read the 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.
- Conditions
- Pregnancy Related, Hypothyroidism, Hyperthyroidism
- Keywords
- Hyperthyroidism, Polymorphism, TSHβX1, D2 THR92ALA, Hypothyroidism
- Medical subject headings
- Hypothyroidism, Hyperthyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
TSHβX1 splice variant expression.
Frequency of positive cases for the TSHβX1 splice variant identified by real-time polymerase change reaction.
Measured: Baseline.
Secondary outcomes (1)
D2 Thr92Ala polymorphism.
Allele frequency identification of the D2 Thr92Ala polymorphism by genotyping method.
Measured: Baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2018
- Study start1 Sep 2016
- Primary completion15 Dec 2017
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Materno-Perinatal Hospital of the State of Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Autonoma del Estado de Mexico, Ciprés Grupo Médico CGM SC
- Responsible party
- Principal investigator, Hugo Mendieta Zeron, Materno-Perinatal Hospital of the State of Mexico
- Investigators
- Mendieta Zerón, Principal investigator, Hospital Materno-Perinatal "Mónica Pretelini Sáenz".
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03612908
- Sponsor's protocol ID
- 217B500402016054
- Status last verified
- Jul 2018
- First submitted
- 20 Jul 2018
- Last updated
- 2 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The information will be available for academic journals if needed.
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.
PubMed 27786042Leung 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.
PubMed 22658718
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TSHβX1 Splice Variant Expression and D2 Thr92Ala Polymorphism Analysis in Pregnant Women With Thyroid Diseases
- ClinicalTrials.gov ID
- NCT03612908
- Acronym / sponsor ID
- 217B500402016054
- Conditions
- Pregnancy Related, Hypothyroidism, Hyperthyroidism
- Keywords
- Hyperthyroidism, Polymorphism, TSHβX1, D2 THR92ALA, Hypothyroidism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Materno-Perinatal Hospital of the State of MexicoUniversity, hospital or other
- Collaborators
- Universidad Autonoma del Estado de Mexico, Ciprés Grupo Médico CGM SC
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 15 Dec 2017 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 2 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women attended at the "Mónica Pretelini Sáenz" Maternal-Perinatal Hospital are mainly of low socioeconomical status.
Key inclusion criteria (1 listed)
- Pregnant women attended at the "Mónica Pretelini Sáenz" Maternal-Perinatal Hospital (HMPMPS), Health Institute of the State of Mexico (ISEM), Toluca, Mexico.
Key exclusion criteria (2 listed)
- Patients with chronic diseases other than hyper or hypothyroidism.
- Patients that required attention in the obstetric intensive care unit.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
TSHβX1 splice variant expression.
Time frame: Baseline.
Frequency of positive cases for the TSHβX1 splice variant identified by real-time polymerase change reaction.
1 secondary outcome
D2 Thr92Ala polymorphism.
Time frame: Baseline.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2018.
- Background: PubMed 27786042Wouters 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.
- Background: PubMed 22658718Leung 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.
- PREDICTED: Homo sapiens thyroid stimulating hormone beta (TSHB), transcript variant X1.Link provided by the sponsor.
- Individual participant dataSharing planned: No. The information will be available for academic journals if needed.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mendieta Zerón principal investigator
Hospital Materno-Perinatal "Mónica Pretelini Sáenz".
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Related and Hypothyroidism, run by Materno-Perinatal Hospital of the State of Mexico at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TSHβX1 splice variant expression. (time frame: Baseline.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03612908, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2018.