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NCT Number: NCT02399475

Mechanistic Study of Subclinical Hypothyroidism In the Elderly

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.

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Key information

Conditions

Subclinical Hypothyroidism Endocrine System Diseases Hypothyroidism Thyroid Diseases

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 <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

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

Treatment and study plan

Levothyroxine

Drug

Oral levothyroxine with a total starting dose of 0.7mcg/kg/day split into three daily doses will be titrated to a target TSH level of 0.5 -1.5mU/L

Other names: Synthroid

liothyronine

Drug

Oral liothyronine with a starting dose of 1/3 of the weight-based LT4 dose divided into three daily doses titrated to a target TSH level of 0.5 -1.5mU/L

Other names: Cytomel

thyrotropin-releasing hormone

Drug

200 µg intravenous TRH will be given at study visit 1 (baseline), study visit 2 (on first thyroid treatment), and study visit 3 (on second thyroid treatment).

Primary outcomes

  1. TSH Area Under the Curve

    Time frame: 0, 5, 10, 15, 20, 30, and 60 min post TRH

    TSH area under the curve within 60 minutes of TRH stimulation when TSH is at goal

  2. TSH Max

    Time frame: Between 0 and 180 min after TRH stimulation

    The maximum concentration of TSH after TRH stimulation when TSH is at goal

  3. Free T4 Level

    Time frame: An average of 7 months after initiating therapy

    Free thyroxine level when TSH level is at goal on therapy.

  4. Total T3 Level

    Time frame: An average of 7 months

    Total triiodothyronine level when TSH is at goal on therapy

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

The Thyroid Axis in Older Individuals With Persistent Subclinical Hypothyroidism: a Mechanistic, Randomized, Double-Blind, Cross-Over Study of Levothyroxine and Liothyronine Administration

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Mar 26, 2015
Registry last updated
Mar 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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