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Search / Trial NCT02399475

Mechanistic Study of Subclinical Hypothyroidism In the Elderly

Launched by UNIVERSITY OF PENNSYLVANIA · Mar 20, 2015

Trial Information

Current as of May 07, 2025

Completed

Keywords

Levothyroxine Liothyronine Thyrotropin Releasing Hormone Aging Hypothyroidism Thyroid Diseases

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. men and women aged 70 and older
  • 2. TSH between 4.5 and 19.9 mU/L as an outpatient
  • 3. ability to provide informed consent
  • Exclusion Criteria:
  • Laboratory Tests:
  • 1. TSH \<4.5 mU/L or \>20 mU/L on repeat testing at least four weeks later or free T4 level outside the reference range
  • 2. thyroid peroxidase (TPO) antibody positive
  • 3. abnormal liver function tests (LFTs \>3 x upper limit of normal)
  • 4. hemoglobin \<11 g/dL
  • Surgeries or Procedures:
  • 1. thyroid surgery
  • 2. pituitary surgery
  • 3. bariatric surgery
  • 4. bowel resection involving the jejunum and upper ileum
  • 5. radioactive iodine therapy
  • 6. radiation treatments to head or neck
  • Medical Conditions:
  • 1. diagnosis of pituitary disease
  • 2. diagnosis of amyloidosis, sarcoidosis, hemochromatosis
  • 3. diagnosis of adrenal insufficiency
  • 4. obesity with BMI \> 35 mg/kg2
  • 5. history of stroke
  • 6. chronic or ongoing angina, Class II or higher congestive heart failure, or uncontrolled hypertension with current blood pressure greater than 160/100
  • 7. diabetes mellitus with hemoglobin A1C level greater than 8.0% in the past six months
  • 8. celiac sprue, Crohn's disease, ulcerative colitis, Zollinger-Ellison syndrome
  • 9. renal insufficiency with calculated glomerular filtration rate \<45 cc/min
  • 10. cognitive impairment with Mini Mental State Exam\[30\] \<24/30
  • 11. history of any seizures
  • 12. unstable medical or psychological condition in the judgment of the principal investigator
  • Medications:
  • 1. thyroid hormone preparations
  • 2. antithyroid drugs
  • 3. medications that interfere with the absorption or metabolism of thyroid hormone
  • 4. medications that interfere with the TRH stimulation test
  • 5. proton pump inhibitors

About University Of Pennsylvania

The University of Pennsylvania, a prestigious Ivy League institution located in Philadelphia, is renowned for its commitment to advancing medical research and improving healthcare outcomes. As a clinical trial sponsor, the university leverages its extensive resources, interdisciplinary expertise, and cutting-edge facilities to conduct innovative studies across various therapeutic areas. With a focus on translating scientific discoveries into clinical applications, the University of Pennsylvania fosters collaborations among leading researchers, clinicians, and industry partners, ensuring rigorous trial design and adherence to ethical standards. Through its dedication to excellence in research and education, the university plays a pivotal role in shaping the future of medicine.

Locations

Philadelphia, Pennsylvania, United States

Patients applied

0 patients applied

Trial Officials

Anne R Cappola, MD, ScM

Principal Investigator

The University of Pennsylvania

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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