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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) )
ClinicalTrials.gov Identifier:
NCT00054756
First received: February 7, 2003
Last updated: October 28, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
Healthy
Pituitary Disease
Thyroid Disease
Drug: TRH (Thyrotropin Releasing Hormone)
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Study of Thyrotropin Releasing Hormone in Patients With Thyroid or Pituitary Abnormalities

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • TSH response to TRH

Estimated Enrollment: 99999999
Study Start Date: February 2003
Estimated Study Completion Date: January 2099
Estimated Primary Completion Date: January 2099 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: TRH (Thyrotropin Releasing Hormone)
    N/A
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   2 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00054756

Contacts
Contact: Craig S Cochran, R.N. (301) 402-1880 craigc@bdg10.niddk.nih.gov
Contact: Monica C Skarulis, M.D. (301) 496-6087 monicas@intra.niddk.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Monica C Skarulis, M.D. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  More Information

Additional Information:
Publications:
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) )
ClinicalTrials.gov Identifier: NCT00054756     History of Changes
Other Study ID Numbers: 030098, 03-DK-0098
Study First Received: February 7, 2003
Last Updated: October 28, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Hypothalamic Releasing Factor
Neuropeptide
Diagnostic Testing
Pituitary Tumors
Central Hypothyroidism
Pituitary Disorder
Thyroid Disorder
Healthy Volunteer
HV

Additional relevant MeSH terms:
Pituitary Diseases
Thyroid Diseases
Brain Diseases
Central Nervous System Diseases
Endocrine System Diseases
Hypothalamic Diseases
Nervous System Diseases
Hormones
Thyrotropin-Releasing Hormone
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014