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
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Philadelphia, Pennsylvania, United States
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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