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Search / Trial NCT05435547

Preoperative Corticosteroids in Autoimmune Thyroid Disease

Launched by INDIANA UNIVERSITY · Jun 23, 2022

Trial Information

Current as of July 22, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is exploring whether taking corticosteroids for a short time before surgery can help patients with autoimmune thyroid diseases like Graves' disease and Hashimoto's disease. The goal is to see if these medications can reduce inflammation in the thyroid gland, which might make the surgery easier and safer. If you have one of these conditions and are planning to have your thyroid removed (a procedure called total thyroidectomy), you might be eligible to participate in this study.

To join the trial, you should be between the ages of 65 and 74 and have positive thyroid autoantibodies, which are markers that indicate your body is attacking the thyroid. However, if you've had prior treatments for thyroid cancer, have undergone neck surgeries before, or are on certain medications for diabetes or other autoimmune diseases, you may not qualify. Participants in the study can expect to be randomly assigned to receive either corticosteroids or a placebo (a treatment that looks like the real thing but has no active medication) before their surgery. This is a great opportunity to help researchers learn more about managing these thyroid conditions and improving surgical outcomes for future patients.

Gender

ALL

Eligibility criteria

  • * Inclusion Criteria:
  • ■ Graves' disease or Hashimoto's disease with positive thyroid autoantibodies (TgAb, TPO, TSI, and/or TRAb) undergoing total thyroidectomy for their disease.
  • * Exclusion Criteria:
  • Pediatric patients \< 18
  • Prior treatment with RAI
  • Prior neck surgeries
  • Known diagnosis of thyroid cancer
  • Diabetic patients on medications
  • A history of adverse reactions to corticosteroids.
  • Patients on any immunosuppressive regimen (such as organ transplant patients or patients treated for other autoimmune conditions). This includes patients with recent history of steroid therapy, or a history of adverse reactions to corticosteroids.

About Indiana University

Indiana University, a leading research institution, is committed to advancing healthcare through innovative clinical trials and rigorous scientific inquiry. With a focus on improving patient outcomes, the university conducts a wide range of studies across various medical disciplines, leveraging its extensive resources and collaborative networks. Indiana University's dedication to ethical research practices and community engagement ensures that its clinical trials not only contribute to scientific knowledge but also prioritize participant safety and well-being. Through its commitment to excellence, Indiana University plays a pivotal role in shaping the future of medicine and enhancing public health.

Locations

Indianapolis, Indiana, United States

Indianapolis, Indiana, United States

Indianapolis, Indiana, United States

Indianapolis, Indiana, United States

Indianapolis, Indiana, United States

Indianapolis, Indiana, United States

Patients applied

0 patients applied

Trial Officials

Alexandria McDow, MD

Principal Investigator

Indiana University School of Medicine

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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