N/A N=14 Randomized Double-blind Other

Mechanistic Study of Subclinical Hypothyroidism In the Elderly

Subclinical Hypothyroidism

Bottom Line

View on ClinicalTrials.gov: NCT02399475 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2021

Primary outcome: Primary: TSH Area Under the Curve — 267.8; 266.2 μIU*min/mL

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Levothyroxine (Drug); Liothyronine (Drug); Thyrotropin-Releasing Hormone (Drug)
Age: Older Adult · 70+ yrs
Sex: All
Sponsor: University of Pennsylvania
Primary completion: Sep 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY TSH Area Under the Curve	267.8; 266.2	—
PRIMARY TSH Max	5.5; 5.4	—
PRIMARY Free T4 Level	1.65; 0.46	—
PRIMARY Total T3 Level	1.12; 1.98	—

Summary

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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

Laboratory Tests:

TSH 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 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

Medications:

thyroid hormone preparations
antithyroid drugs
medications that interfere with the absorption or metabolism of thyroid hormone
medications that interfere with the TRH stimulation test
proton pump inhibitors

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02399475). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.