CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 16 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01441154
NCT01441154N/ACompleted

Pharmacokinetic and Pharmacodynamic Studies of Liothyronine. A Study on the Metabolic Effects of Thyroid Hormone

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·observational·Posted Sep 27, 2011·Updated Sep 28, 2020

In Brief

An observational study for Malignant Struma Ovarii and 4 related conditions. Completed, enrolled 16 participants across 1 site.

Detailed Summary

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: * The study involves a screening visit and a baseline evaluation. It also includes an 11-day inpatient hospital stay. * Participants will be screened with a physical exam and medical history. They will also have blood tests and a neck ultrasound. * Participants will be evaluated with a physical exam, blood tests, and the following procedures: * Glucose tolerance test to measure blood sugar * Tests of body fat, muscle strength, and calorie burning levels * Imaging studies of the heart, liver, and thigh muscles * Quality of life questionnaires * Food preference and diet questionnaires * After 4 weeks of treatment with T3 hormone, participants will have an 11-day inpatient hospital stay to study the effect of thyroid hormone on their metabolism. The stay will involve the same tests done in the baseline evaluation.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedSep 27, 2011
Enrollment StartSep 20, 2011
Primary CompletionDec 12, 2013
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 14.8 years ago