Mechanistic Study of Subclinical Hypothyroidism In the Elderly
Information source: University of Pennsylvania
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Subclinical Hypothyroidism
Intervention: Levothyroxine (Drug); Liothyronine (Drug); Thyrotropin-Releasing Hormone (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: University of Pennsylvania Official(s) and/or principal investigator(s): Anne Cappola, MD, ScM, Principal Investigator, Affiliation: The University of Pennsylvania
Overall contact: Paige Meizlik, MD, Phone: 215-746-1151, Email: paige.meizlik@uphs.upenn.edu
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.
Clinical Details
Official title: The Thyroid Axis in Older Individuals With Persistent Subclinical Hypothyroidism: a Mechanistic, Randomized, Double-Blind, Cross-Over Study of Levothyroxine and Liothyronine Administration
Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)
Primary outcome: TSH area under the curveTSH Max Free T4 Level Total T3 Level TSH bioactivity measurement
Secondary outcome: Unstimulated TSH bioactivityResting energy expenditure (REE) evaluation Weight Body Fat Percent Body Fat Total Free Fat Mass Bone Density Lipid Profile SF-36 Heart Rate Physical Activity Digit Symbol Substitution Test Body Temperature Hypothyroid Symptom Questionnaire
Eligibility
Minimum age: 70 Years.
Maximum age: N/A.
Gender(s): Both.
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
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. history of myocardial infarction, coronary artery bypass graft surgery or
percutaneous coronary angioplasty, angina, atrial fibrillation, 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
Locations and Contacts
Paige Meizlik, MD, Phone: 215-746-1151, Email: paige.meizlik@uphs.upenn.edu
University of Pennsylvania, Philadelphia, Pennsylvania 19104, United States; Recruiting
Additional Information
Starting date: January 2015
Last updated: March 20, 2015
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