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Metabolic Effects of Synthetic Thyroid Hormone for Thyroid Cancer Treatment

NCT01441154 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 16

Last updated 2020-09-28

No results posted yet for this study

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.

Conditions

  • Malignant Struma Ovarii
  • Papillary Thyroid Cancer
  • Hurthle Cell Thyroid Cancer
  • Follicular Thyroid Cancer
  • Tall Cell Variant Thyroid Cancer

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    lead NIH

Principal Investigators

  • Kong Y Chen, Ph.D. · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-20
Primary Completion
2013-12-12
Completion
2013-12-12

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01441154 on ClinicalTrials.gov