Study of Thyrotropin-Releasing Hormone in Normal Volunteers and in Patients With Thyroid or Pituitary Abnormalities
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies, Women's Studies, Endocrine |
| Therapuetic Areas: | Endocrinology, Other, Reproductive |
| Healthy: | No |
| Age Range: | 2 - Any |
| Updated: | 8/10/2018 |
| Start Date: | February 7, 2003 |
| End Date: | September 26, 2014 |
Study of Thyrotropin Releasing Hormone in Patients With Thyroid or Pituitary Abnormalities
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.
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.
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.
Under this protocol, TRH is used for routine diagnostic testing and research studies in
adults and children. It is produced by the Pharmaceutical Development Section of the Clinical
Center Pharmacy at the NIH. The safety, activity and comparability of this preparation were
demonstrated in a small group of normal volunteers prior to its release for diagnostic and
research use.
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.
Under this protocol, TRH is used for routine diagnostic testing and research studies in
adults and children. It is produced by the Pharmaceutical Development Section of the Clinical
Center Pharmacy at the NIH. The safety, activity and comparability of this preparation were
demonstrated in a small group of normal volunteers prior to its release for diagnostic and
research use.
- DIAGNOSTIC STUDY PROTOCOL
Inclusion Criteria:
-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.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
Phone: 800-411-1222
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