Correlation Between Levothyroxine and Blood Th17/Treg in Pregnant Women With Normal-high TSH and Positive TPOAb

NCT06527859 | Terminated

• 1 other identifier: ThirdZhengzhouU
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this clinical trial is to understand the impact of different doses of levothyroxine on the immune inflammatory response in pregnant women with normal-high TSH and positive TPOAb in the first half of pregnancy. It aims to answer the main questions: Are there differences in immune inflammation between normal pregnant women and those in the disease group? Can different doses of levothyroxine improve the Th17/Treg ratio and cytokine levels in the disease group? Researchers first compared the differences between normal pregnant women and those in the disease group, and then administered two different doses of levothyroxine to the disease group to observe whether different doses of levothyroxine can improve the immune inflammation in this group. pregnant women in the disease group will: Take the same dose of levothyroxine (25/50ug) every day Return for a follow-up visit after 4 weeks of medication

Conditions

Pregnancy Related; Thyroid Stimulating; Hormone, C

Keywords

levothyroxine; thyroid stimulating hormone; thyroid peroxidase antibodies; immunity; Th17/Treg

Outcome Measures

Primary Outcomes (1)

• Th17/Treg

  Ratio of Th17 to Treg percentages in peripheral blood.

  4 weeks

Secondary Outcomes (1)

• cytokines, inflammatory factor

  4 weeks

Other Outcomes (1)

• lipids, Small intestinal bacterial overgrowth

  4 weeks

Study Arms (2)

control group

healthy pregnancy women

disease group

pregnant women with normal-high TSH and positive TPOAb in the first half of pregnancy

Drug: Levothyroxin

Interventions

Levothyroxin DRUG

The disease group were divided into two groups ,25ugLT4 (HA group, n=17) and 50ugLT4 (HB group, n=17) respectively.

disease group

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The population that meets the inclusion and exclusion criteria and is willing to participate in the research.

You may qualify if:

• Thyroid function level meets the specific reference range established by the laboratory department of our hospital based on the "Guidelines for the prevention and management of thyroid diseases during pregnancy and perinatal period" : FT4: 12-22pmol/L; disease group: TPOAb\>;34IU/mL, TSH: 2.5mIU/L-upper limit of reference range; control group: TPOAb≤34IU/mL, TSH\<2.5mIU/L;
• All pregnant women are in the first half of pregnancy (gestational age≤20 weeks).

You may not qualify if:

• Combined with hypothyroidism, subclinical hypothyroidism, and hyperthyroidism;
• Assisted reproduction;
• Multiple pregnancy;
• Combined with other autoimmune diseases such as antiphospholipid syndrome and thrombophilia;
• Severe intestinal diseases or intestinal surgery history, or the use of probiotics, prebiotics and other drugs that affect intestinal flora;
• Obesity, pre-pregnancy hyperlipidemia;
• Adverse reactions to LT4

Sponsors & Collaborators

• Third Affiliated Hospital of Zhengzhou University: lead

Study Sites (1)

The Third Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Location

Related Publications (18)

• Lasa M, Contreras-Jurado C. Thyroid hormones act as modulators of inflammation through their nuclear receptors. Front Endocrinol (Lausanne). 2022 Aug 8;13:937099. doi: 10.3389/fendo.2022.937099. eCollection 2022.

  PMID: 36004343 BACKGROUND

• Michalopoulou G, Alevizaki M, Piperingos G, Mitsibounas D, Mantzos E, Adamopoulos P, Koutras DA. High serum cholesterol levels in persons with 'high-normal' TSH levels: should one extend the definition of subclinical hypothyroidism? Eur J Endocrinol. 1998 Feb;138(2):141-5. doi: 10.1530/eje.0.1380141.

  PMID: 9506856 BACKGROUND

• Cayres LCF, de Salis LVV, Rodrigues GSP, Lengert AVH, Biondi APC, Sargentini LDB, Brisotti JL, Gomes E, de Oliveira GLV. Detection of Alterations in the Gut Microbiota and Intestinal Permeability in Patients With Hashimoto Thyroiditis. Front Immunol. 2021 Mar 5;12:579140. doi: 10.3389/fimmu.2021.579140. eCollection 2021.

  PMID: 33746942 BACKGROUND

• Xue H, Yu X, Ma L, Song S, Li Y, Zhang L, Yang T, Liu H. The possible role of CD4(+)CD25(high)Foxp3(+)/CD4(+)IL-17A(+) cell imbalance in the autoimmunity of patients with Hashimoto thyroiditis. Endocrine. 2015 Dec;50(3):665-73. doi: 10.1007/s12020-015-0569-y. Epub 2015 Mar 13.

  PMID: 25771887 BACKGROUND

• undefined

  BACKGROUND

• Xue H, Yang Y, Zhang Y, Song S, Zhang L, Ma L, Yang T, Liu H. Macrophage migration inhibitory factor interacting with Th17 cells may be involved in the pathogenesis of autoimmune damage in Hashimoto's thyroiditis. Mediators Inflamm. 2015;2015:621072. doi: 10.1155/2015/621072. Epub 2015 Mar 15.

  PMID: 25861163 BACKGROUND

• Lee SY, Pearce EN. Assessment and treatment of thyroid disorders in pregnancy and the postpartum period. Nat Rev Endocrinol. 2022 Mar;18(3):158-171. doi: 10.1038/s41574-021-00604-z. Epub 2022 Jan 4.

  PMID: 34983968 BACKGROUND

• Yetkin DO, Dogantekin B. The Lipid Parameters and Lipoprotein(a) Excess in Hashimoto Thyroiditis. Int J Endocrinol. 2015;2015:952729. doi: 10.1155/2015/952729. Epub 2015 May 3.

  PMID: 26064115 BACKGROUND

• Sinha RA, Singh BK, Yen PM. Direct effects of thyroid hormones on hepatic lipid metabolism. Nat Rev Endocrinol. 2018 May;14(5):259-269. doi: 10.1038/nrendo.2018.10. Epub 2018 Feb 23.

  PMID: 29472712 BACKGROUND

• Kim HJ, Park SJ, Park HK, Byun DW, Suh K, Yoo MH. Thyroid autoimmunity and metabolic syndrome: a nationwide population-based study. Eur J Endocrinol. 2021 Oct 11;185(5):707-715. doi: 10.1530/EJE-21-0634.

  PMID: 34519275 BACKGROUND

• Ru X, Yang M, Teng Y, Han Y, Hu Y, Wang J, Tao F, Huang K. Association of maternal thyroid peroxidase antibody during pregnancy with placental morphology and inflammatory and oxidative stress responses. Front Endocrinol (Lausanne). 2023 Sep 22;14:1182049. doi: 10.3389/fendo.2023.1182049. eCollection 2023.

  PMID: 37810887 BACKGROUND

• Mahto M, Chakraborthy B, Gowda SH, Kaur H, Vishnoi G, Lali P. Are hsCRP Levels and LDL/HDL Ratio Better and Early Markers to Unmask Onset of Dyslipidemia and Inflammation in Asymptomatic Subclinical Hypothyroidism? Indian J Clin Biochem. 2012 Jul;27(3):284-9. doi: 10.1007/s12291-012-0206-y. Epub 2012 Apr 18.

  PMID: 26405389 BACKGROUND

• Cao Y, Jin X, Sun Y, Wen W. Therapeutic effect of mesenchymal stem cell on Hashimoto's thyroiditis in a rat model by modulating Th17/Treg cell balance. Autoimmunity. 2020 Feb;53(1):35-45. doi: 10.1080/08916934.2019.1697689. Epub 2019 Dec 3.

  PMID: 31793369 BACKGROUND

• Vaivode I, Zake T, Strele I, Upmale-Engela S, Gogins D, Gersone G, Skesters A, Dambrova M, Konrade I. Stress-Related Immune Response and Selenium Status in Autoimmune Thyroid Disease Patients. Int J Mol Sci. 2023 Jan 26;24(3):2440. doi: 10.3390/ijms24032440.

  PMID: 36768762 BACKGROUND

• Mazzieri A, Montanucci P, Basta G, Calafiore R. The role behind the scenes of Tregs and Th17s in Hashimoto's thyroiditis: Toward a pivotal role of FOXP3 and BACH2. Front Immunol. 2022 Dec 12;13:1098243. doi: 10.3389/fimmu.2022.1098243. eCollection 2022.

  PMID: 36578493 BACKGROUND

• Xu Y, Zhao Y, Xu X, Yan Q, Yang L. Serum lipid profile in relation to free thyroxine and the effect of levothyroxine treatment on lipids in patients with isolated hypothyroxinemia during pregnancy: a single-center retrospective study. Lipids Health Dis. 2022 Dec 19;21(1):142. doi: 10.1186/s12944-022-01744-5.

  PMID: 36536397 BACKGROUND

• Yu M, Long Y, Wang Y, Zhang R, Tao L. Effect of levothyroxine on the pregnancy outcomes in recurrent pregnancy loss women with subclinical hypothyroidism and thyroperoxidase antibody positivity: a systematic review and meta-analysis. J Matern Fetal Neonatal Med. 2023 Dec;36(2):2233039. doi: 10.1080/14767058.2023.2233039.

  PMID: 37433649 BACKGROUND

• Fenneman AC, Bruinstroop E, Nieuwdorp M, van der Spek AH, Boelen A. A Comprehensive Review of Thyroid Hormone Metabolism in the Gut and Its Clinical Implications. Thyroid. 2023 Jan;33(1):32-44. doi: 10.1089/thy.2022.0491. Epub 2023 Jan 6.

  PMID: 36322786 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

The samples collected have no extra retention after being processed.

MeSH Terms

Interventions

Thyroxine

Intervention Hierarchy (Ancestors)

Thyroid Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Xin Tian

  Third Affiliated Hospital of Zhengzhou University

  PRINCIPAL INVESTIGATOR

• Yanjie Ban

  Third Affiliated Hospital of Zhengzhou University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Physician

Study Record Dates

• First Submitted: July 14, 2024
• First Posted: July 30, 2024
• Study Start: April 6, 2022
• Primary Completion: October 31, 2023
• Study Completion: June 5, 2024
• Last Updated: July 30, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)