View Clinical Trial (Medical Research Study)
Study of Thyrotropin Releasing Hormone in Patients With Thyroid or Pituitary Abnormalities
| City: |
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Bethesda |
| State: |
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Maryland |
| Zip Code: |
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20892 |
| Conditions: |
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Healthy - Pituitary Disease - Thyroid Disease |
| Purpose: |
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This study will determine the safety and activity of a new formulation of
thyrotropin-releasing hormone (TRH), a drug used for diagnosing and evaluating patients with
certain thyroid gland abnormalities. Normal thyroid gland function depends on proper
chemical signaling between the thyroid gland, the hypothalamus (the part of the brain where
TRH is made), and the pituitary (another part of the brain). The TRH test helps assess this
interaction. Production of the only FDA-approved preparation of TRH was stopped in July
2002. As a result, to have a continuous source of TRH available for NIH clinical and
research purposes, the NIH Clinical Center (CC) Pharmacy Department produced a
pharmaceutical grade formulation of TRH for patient use. This study will test the CC
formulation in healthy volunteers to show that its activity and side effects are similar to
those of the previously available commercial test preparation. It will then be studied in
CC patients for whom the diagnostic test is recommended.
Healthy volunteers between 18 and 65 years of age and all patients requiring TRH evaluation
of hypothalamic-pituitary-thyroid gland interaction may be eligible for this study.
Patients include those with pituitary reserve, inconsistent thyroid function test,
inappropriate TSH secretion, or pre- and post-operative evaluation of pituitary tumors.
Normal volunteers will be screened with a medical history, physical examination, and blood
tests. Women of child-bearing potential will be given a pregnancy test; pregnant and
breast-feeding women may not participate.
The TRH test procedure will be the same for healthy volunteers and patients. All
participants fast from midnight before the morning of the test. In the morning, a catheter
(flexible plastic tube) is inserted into an arm vein for easy injection of the TRH and
collection of blood samples. Blood pressure is monitored before and during the test. A
blood sample is drawn, and then TRH is given through the catheter over a 1-minute period.
Another nine blood samples are collected over a 3-hour period from the time of the TRH
injection for measuring levels of various hormones. A total of less than 4 tablespoons of
blood is taken for the test.
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| Study Summary: |
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Thyrotropin releasing hormone (TRH) is a neuropeptide used in the diagnostic evaluation of
patients with dysfunction of the hypothalamic-pituitary-thyroid (HPT) axis. In healthy
individuals, administration of TRH intravenously results in pituitary secretion of
thyrotropin [thyroid-stimulating hormone (TSH)], which in turn stimulates the thyroid gland
release of thyroid hormones; thyroxine (T4) and triiodothyronine (T3). TRH stimulates the
secretion of other pituitary hormones under normal physiologic as well as pathologic
conditions. The purpose of this study is to test the safety and activity of a new
preparation of TRH produced by the Pharmaceutical Development Section of the Clinical Center
Pharmacy at the NIH. This preparation is similar to a previously commercially available
preparation. Normal, healthy adults will be recruited to undergo a standard TRH test using
the new preparation. TSH, prolactin and thyroid hormones are measured after the
administration of TRH. After the safety, activity and diagnostic comparability are
established, the preparation will be used for routine diagnostic testing and research in
adults and children.
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| Criteria: |
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- INCLUSION CRITERIA:
Diagnostic Study Protocol
All adults and children requiring dynamic testing of the hypothalamic-pituitary axis for
the evaluation of pituitary reserve, inconsistent thyroid function test, inappropriate TSH
secretion, or pre-and post-operative evaluation of pituitary adenomas (glycoprotein
hormone secreting tumors, growth hormone secreting tumors and TSH secreting tumors).
EXCLUSION CRITERIA:
- Uncontrolled hypertension;
- Uncontrolled seizure disorder;
- Unstable coronary disease;
- Known allergy to TRH.
Research protocols
TRH is available for use in other IRB approved research protocols either using the
standard diagnostic testing protocol or the modified TRH test.
EXCLUSION CRITERIA:
- Untreated hypertension;
- Coronary artery disease;
- History of asthma;
- History of seizures;
- Pregnancy;
- Known allergy to TRH.
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| NCT ID: |
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NCT00054756 |
| Primary Contact: |
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Principal Investigator
Monica C Skarulis, M.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Craig S Cochran, R.N.
Phone: (301) 402-1880
Email: craigc@bdg10.niddk.nih.gov
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| Backup Contact: |
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Email: monicas@mail.nih.gov
Monica C Skarulis, M.D.
Phone: (301) 496-6087
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| Location Contact: |
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Bethesda, Maryland 20892
United States
For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)
Phone: 800-411-1222
Email: prpl@mail.cc.nih.gov
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 22, 2013 |
| Modifications to this listing: |
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