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Study of Thyrotropin-Releasing Hormone in Normal Volunteers and in Patients with Thyroid or Pituitary Abnormalities Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on Study of Thyrotropin-Releasing Hormone in Normal Volunteers and in Patients with Thyroid or Pituitary Abnormalities conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Study of Thyrotropin-Releasing Hormone in Normal Volunteers and in Patients with Thyroid or Pituitary Abnormalities Clinical research trials and Study of Thyrotropin-Releasing Hormone in Normal Volunteers and in Patients with Thyroid or Pituitary Abnormalities healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including Study of Thyrotropin-Releasing Hormone in Normal Volunteers and in Patients with Thyroid or Pituitary Abnormalities. Study of Thyrotropin-Releasing Hormone in Normal Volunteers and in Patients with Thyroid or Pituitary Abnormalities Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a Study of Thyrotropin-Releasing Hormone in Normal Volunteers and in Patients with Thyroid or Pituitary Abnormalities clinical trial. Participants typically obtain the most effective healthcare available for their Study of Thyrotropin-Releasing Hormone in Normal Volunteers and in Patients with Thyroid or Pituitary Abnormalities condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "S" Clinical Trials Conditions > Study of Thyrotropin-Releasing Hormone in Normal Volunteers and in Patients with Thyroid or Pituitary Abnormalities  Study of Thyrotropin-Releasing Hormone in Normal Volunteers and in Patients with Thyroid or Pituitary Abnormalities
Study of Thyrotropin-Releasing Hormone in Normal Volunteers and in Patients with Thyroid or Pituitary Abnormalities
For Condition: Healthy,Pituitary Disease,Thyroid Disease
Status: Recruiting
Sponsor(s): National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) ,
Synopsis: 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.
Details: Thyrotropin releasing hormone (TRH) is a neuropeptide used in the diagnostic evaluation of patient with dysfunction of the hypothalamic-pituitary-thyroid (HPT) axis. In healthy individuals, administration of TRH intravenously results in pituitary secretion of thyrotropin [thyroid-stimulation 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, health 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 studies in adults and children.
Eligibility:
Study Type: Interventional, Treatment, Safety/Efficacy
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA - Healthy Volunteer Study: Healthy males and females between the ages of 18 and 65 years. EXCLUSION CRITERIA - Healthy Volunteer Study: Hypertension; Coronary artery disease; History of asthma; History of seizures; Chronic liver, kidney, thyroid or pituitary disease; Use of medications for chronic conditions, contraception or hormone replacement; Pregnancy; Known allergy to TRH. 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 - Diagnostic Study Protocol: Uncontrolled hypertension; Uncontrolled seizure disorder; Unstable coronary disease; Known allergy to TRH.
Total Enrollment: 99999
Location and Contact Information:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Patient and Public Liaison Office 1-800-411-1222
Additional Information:
Study ID Numbers: 030098; 03-DK-0098
Study Start Date: February 6, 2003
Record last reviewed: November 6, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00054756
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