Protocol Number: 03-DK-0098

Title:

Study of Thyrotropin Releasing Hormone in Normal Volunteers and in Patients with Thyroid or Pituitary Abnormalities

Number:

03-DK-0098

Summary:

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.

Sponsoring Institute:

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

Recruitment Detail

Type: Active Accrual Of New Subjects

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): None

Eligibility Criteria:

INCLUSION CRITERIA:

Healthy Volunteer Study:

1. Healthy males and females between the ages of 18 and 65 years.

Diagnostic Study Protocol:

1. 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:

Healthy Volunteer Study:

1. Hypertension;

2. Coronary artery disease;

3. History of asthma;

4. History of seizures;

5. Chronic liver, kidney, thyroid or pituitary disease;

6. Use of medications for chronic conditions, contraception or hormone replacement;

7. Pregnancy;

8. Known allergy to TRH.

Diagnostic Study Protocol:

1. Uncontrolled hypertension;

2. Uncontrolled seizure disorder;

3. Unstable coronary disease;

4. Known allergy to TRH.

Research Protocols:

1. Untreated hypertension;

2. Coronary artery disease;

3. History of asthma;

4. History fo seizures

5. Pregnancy;

6. Known allergy to TRH.

Special Instructions: Currently Not Provided

Keywords:

Hypothalamic Releasing Factor

Neuropeptide

Diagnostic Testing

Pituitary Tumors

Central Hypothyroidism

Recruitment Keywords:

Pituitary Disorder

Thyroid Disorder

Healthy Volunteer

HV

Conditions:

Healthy

Pituitary Disease

Thyroid Disease

Investigational Drug(s):

TRH (Thyrotropin Releasing Hormone)

Investigational Device(s):

None

Contacts:

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citations:

Jackson IM. Thyrotropin-releasing hormone.

N Engl J Med. 1982 Jan 21;306(3):145-55. Review. No abstract available.

PMID: 6798440

Haigler ED Jr, et al. Direct evaluation of pituitary thyrotopin reserve utilizing synthetic thyrotopin releasing hormone.

J Clin Endocrinol Metab. 1971 Oct;33(4):573-81. No abstract available.

PMID: 4999252

Faglia G. The clinical impact of the thyrotropin-releasing hormone test. Thyroid. 1998 Oct;8(10):903-8. Review.

PMID: 9827657

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