Mechanistic Study of Subclinical Hypothyroidism In the Elderly

Completed · Not applicable

Conditions studied: Subclinical Hypothyroidism

In brief

Subclinical hypothyroidism, defined as an elevated TSH in the setting of normal thyroid hormone levels, is a common diagnosis in the elderly. The purpose of this study is to examine the hypothalamic-pituitary-thyroid axis in men and women aged 70 years and older with persistent subclinical hypothyroidism. To evaluate the mechanism behind this condition, participants will undergo thyrotropin releasing hormone stimulation testing at 3 visits: baseline and while taking two different thyroid hormone preparations, levothyroxine and liothyronine. The investigators will also assess physiologic responses to these two different thyroid hormone medications to help us understand how the thyroid works in advanced age.

Key facts

Study ID

NCT02399475

Run by

University of Pennsylvania

People needed

14

Starts

2015-01-01

Expected to finish

2019-09-30

Last updated by the study team

2021-03-09

Who can join

Age: 70 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• men and women aged 70 and older
• TSH between 4.5 and 19.9 mU/L as an outpatient
• ability to provide informed consent

You may not qualify if…

• Laboratory Tests:
• 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
• thyroid peroxidase (TPO) antibody positive
• abnormal liver function tests (LFTs >3 x upper limit of normal)
• hemoglobin <11 g/dL
• Surgeries or Procedures:
• thyroid surgery
• pituitary surgery
• bariatric surgery
• bowel resection involving the jejunum and upper ileum
• radioactive iodine therapy
• radiation treatments to head or neck
• Medical Conditions:
• diagnosis of pituitary disease
• diagnosis of amyloidosis, sarcoidosis, hemochromatosis
• diagnosis of adrenal insufficiency
• obesity with BMI > 35 mg/kg2
• history of stroke
• chronic or ongoing angina, Class II or higher congestive heart failure, or uncontrolled hypertension with current blood pressure greater than 160/100
• diabetes mellitus with hemoglobin A1C level greater than 8.0% in the past six months
• celiac sprue, Crohn's disease, ulcerative colitis, Zollinger-Ellison syndrome
• renal insufficiency with calculated glomerular filtration rate <45 cc/min
• cognitive impairment with Mini Mental State Exam[30] <24/30
• history of any seizures
• unstable medical or psychological condition in the judgment of the principal investigator

Where it is running

• University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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