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Effects of Thyroid Hormone Enzyme Blocking on Hypothyroidism

NCT01801033 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2017-10-06

No results posted yet for this study

Summary

Background:

\- Hypothyroidism is a condition caused by the loss of function of the thyroid gland. The thyroid gland produces two hormones, T4 and T3. These hormones control the metabolism and function of many organs. Lack of energy, depression, and constipation are common symptoms of hypothyroidism. T4 is converted into T3, the active form of thyroid hormone, by two enzymes called deiodinases. People with hypothyroidism are treated with a synthetic T4 hormone, which the enzymes convert to T3. This treatment is usually effective, but some people continue to have symptoms even after treatment. Some researchers think that this may be caused by a problem with the enzymes that convert T4 into T3. They want to look at how the enzymes regulate the levels of T4 and T3 in the blood. They will do so by using a drug that blocks the action of one of the two enzymes.

Objectives:

\- To look at how thyroid hormone enzyme blocking affects hypothyroidism treatment medication.

Eligibility:

\- Individuals at least 18 years of age who have hypothyroidism and are on thyroid hormone replacement therapy.

Design:

* The study consists of one screening visit, 9 days of inpatient hospital admission, and a follow-up visit 2 weeks after discharge.
* Participants will be screened with a physical exam and medical history. They will provide blood samples.
* Participants will receive balanced-diet meals to take home for the 2 days before they enter the hospital. They will continue this diet while in the hospital.
* During the inpatient stay, participants will be monitored with regular blood tests. They will have the following procedures:
* Continued thyroid hormone replacement for all 9 days.
* Drug to block thyroid enzyme for 7 days.
* Metabolism test, with room temperature changes, on days 1, 2, 5, 8, and 9.
* Measurements of body fat on days 2, 5, and 8.
* Blood glucose tests on days 1 and 9.
* Muscle contraction tests on days 1, 2, 4, 5, 8, and 9.
* Heart imaging studies on days 2, 5, and 8.
* Optional skeletal muscle and fat tissue biopsies on days 1 and 9.
* There will be a follow-up visit 2 weeks after leaving the hospital. Participants will have a final physical exam and provide blood samples.

Conditions

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

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

    lead NIH

Principal Investigators

  • Francesco S Celi, M.D. · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-04
Primary Completion
2013-11-29
Completion
2013-11-29

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Diseases

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 NCT01801033 on ClinicalTrials.gov