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Pharmacokinetic and Pharmacodynamic Studies of Liothyronine. A Study on the Metabolic Effects of Thyroid Hormone
Sponsor study identifier
Secondary identifiers
observational
16
1 country
1
Study Start
September 20, 2011
Actual (reported)Primary Completion
December 12, 2013
Actual (reported)Study Completion
December 12, 2013
Actual (reported)Background: \- Thyroid hormone is produced by the thyroid gland, an organ at the base of the neck. Thyroid hormone controls the body's metabolism and the function of many organs. The thyroid gland produces two forms of thyroid hormone: T4 and T3. People who have thyroid cancer are treated with thyroid hormone therapy (synthetic T4, levothyroxine), which at times needs to be stopped to allow for cancer treatments. At these times, a different form of thyroid hormone (synthetic T3, liothyronine) is used to reduce the symptoms caused by low levels of thyroid hormone. Researchers want to know more about how changes in T3 hormone affect the body and organ function. Objectives: \- To study how changes in T3 hormone levels affect the body and organ function. Eligibility: \- Individuals at least 18 years of age who have had most or all of their thyroid removed to treat thyroid cancer who need to stop taking their regular thyroid hormone dose in preparation for the treatment of thyroid cancer. Design:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 12, 2013
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 20, 2011
Actual (reported)September 24, 2011
Actual (reported)September 27, 2011
Actual (reported)December 12, 2013
Actual (reported)December 12, 2013
Actual (reported)1. To assess the pharmacokinetics of T3 in patients devoid of endogenous or exogenous T4 during acute L-T3 withdrawal at steady- state and after the first L-T3 dose administration
to study T3 kinetics in thyroidectomized patients treated with liothyronine (L- T3) replacement therapy in preparation for diagnostic or therapeutic nuclear medicine procedures for the follow-up and management of differentiated thyroid cancer
4 weeks after stopping L-T4 thyroid hormone replacement therapy and starting L-T3 treatment
2. To estimate the minimal duration of L-T3 therapy withdrawal required to achieve a serum TSH level, equal or greater than 30 uIU/mL, to assure effective 131I therapy for treatment of differentiated thyroid cancer
to study T3 kinetics in thyroidectomized patients treated with liothyronine (L- T3) replacement therapy in preparation for diagnostic or therapeutic nuclear medicine procedures for the follow-up and management of differentiated thyroid cancer
4 weeks after stopping L-T4 thyroid hormone replacement therapy and starting L-T3 treatment
Adults with clinical indication for withdrawal from thyroid hormone replacement therapy in preparation for nuclear medicine imaging or therapeutic procedures with radioactive iodine
primary clinical
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892, United States
Yen PM. Physiological and molecular basis of thyroid hormone action. Physiol Rev. 2001 Jul;81(3):1097-142. doi: 10.1152/physrev.2001.81.3.1097.
Bianco AC, Salvatore D, Gereben B, Berry MJ, Larsen PR. Biochemistry, cellular and molecular biology, and physiological roles of the iodothyronine selenodeiodinases. Endocr Rev. 2002 Feb;23(1):38-89. doi: 10.1210/edrv.23.1.0455.
Nguyen TT, DiStefano JJ 3rd, Yamada H, Yen YM. Steady state organ distribution and metabolism of thyroxine and 3,5,3'-triiodothyronine in intestines, liver, kidneys, blood, and residual carcass of the rat in vivo. Endocrinology. 1993 Dec;133(6):2973-83. doi: 10.1210/endo.133.6.8243325.
Kong Y Chen, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
16 participants (actual enrollment reported by the registry).
First Submitted
September 24, 2011
First Posted
September 27, 2011
Study Start
September 20, 2011
Actual (reported)3. To correlate clinical and biochemical parameters of thyroid hormone action, with circulating levels of T3 during L-T3 therapy withdrawal
to study T3 kinetics in thyroidectomized patients treated with liothyronine (L- T3) replacement therapy in preparation for diagnostic or therapeutic nuclear medicine procedures for the follow-up and management of differentiated thyroid cancer
4 weeks after stopping L-T4 thyroid hormone replacement therapy and starting L-T3 treatment
Contact the study team to confirm eligibility.
Primary Completion
December 12, 2013
Actual (reported)Study Completion
December 12, 2013
Actual (reported)Last Updated
September 28, 2020
Record last verified: 2020-09
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