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Study of Thyrotropin Releasing Hormone in Patients With Thyroid or Pituitary Abnormalities


Phase 2
2 Years
65 Years
Open (Enrolling)
Both
Healthy, Pituitary Disease, Thyroid Disease

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Trial Information

Study of Thyrotropin Releasing Hormone in Patients With Thyroid or Pituitary Abnormalities


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.

Inclusion 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.

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Outcome Measure:

TSH response to TRH

Principal Investigator

Monica C Skarulis, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

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

Authority:

United States: Federal Government

Study ID:

030098

NCT ID:

NCT00054756

Start Date:

February 2003

Completion Date:

December 2099

Related Keywords:

  • Healthy
  • Pituitary Disease
  • Thyroid Disease
  • Hypothalamic Releasing Factor
  • Neuropeptide
  • Diagnostic Testing
  • Pituitary Tumors
  • Central Hypothyroidism
  • Pituitary Disorder
  • Thyroid Disorder
  • Healthy Volunteer
  • HV
  • Congenital Abnormalities
  • Pituitary Diseases
  • Thyroid Diseases

Name

Location
National Institutes of Health Clinical Center, 9000 Rockville Pike Bethesda, Maryland  20892