Mechanistic Study of Subclinical Hypothyroidism In the Elderly (NCT02399475) | Clinical Trial Compass
CompletedNot Applicable
Mechanistic Study of Subclinical Hypothyroidism In the Elderly
United States14 participantsStarted 2015-01-01
Plain-language 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.
Who can participate
Age range
70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
TSH Area Under the Curve
Timeframe: 0, 5, 10, 15, 20, 30, and 60 min post TRH
2
TSH Max
Timeframe: Between 0 and 180 min after TRH stimulation
3
Free T4 Level
Timeframe: An average of 7 months after initiating therapy