Phase I/II Study of Neuroendocrine Dysfunction in Patients With Closed Head Injuries
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|ClinicalTrials.gov Identifier: NCT00006271|
Recruitment Status : Unknown
Verified December 2003 by National Center for Research Resources (NCRR).
Recruitment status was: Active, not recruiting
First Posted : September 12, 2000
Last Update Posted : June 24, 2005
I. Determine the incidence of neuroendocrine dysfunction in patients with closed head injuries admitted to the Transitional Learning Community in Galveston, Texas, for rehabilitation.
|Condition or disease|
PROTOCOL OUTLINE: Phase I: Patients undergo fasting for urine and blood endocrine assessments. First morning urine is collected for measurement of 6-sulphatoxymelatonin (6-SMT). Following a medical history and a physical examination, patients undergo measurement of serum levels of free thyroxine, thyroid stimulating hormone (TSH), prolactin, insulin-like growth factor I (IGF-I), dehydroepiandrosterone-sulfate (DHEA-S), free and total testosterone (males only), and baseline growth hormone (GH). Female patients also provide a menstrual history and undergo screening for hypogonadism. Patients then undergo GH stimulation testing comprised of measurement of serum GH levels before and on 6 occasions during the 3 hours after receiving glucagon IV.
After eating, patients undergo adrenocorticotropic hormone stimulation testing comprised of measurement of serum cortisol levels before and at 45 minutes after receiving corticotropin IV.
Phase II: Beginning at noon on a different day, patients with any abnormal endocrine tests during phase I undergo 24 hour inpatient dynamic testing of the neuroendocrine system. Patients undergo GH stimulation testing comprised of measurement of serum GH levels before and on 4 occasions during the 2 hours after receiving levodopa. Patients also undergo concurrent thyrotropin releasing hormone (TRH) and gonadotropin releasing hormone (GnRH) stimulation testing comprised of measurement of serum TSH and luteinizing hormone (LH) levels before and at 15, 30, 60, and 90 minutes after receiving TRH and GnRH IV. Patients then undergo overnight metyrapone testing comprised of baseline measurement of serum 11-deoxycortisol and cortisol levels, followed by oral metyrapone with a snack, overnight fasting, and then remeasurement of serum 11-deoxycortisol and cortisol levels.
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Study Start Date :||January 1997|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006271
|United States, Texas|
|Transitional Learning Community|
|Galveston, Texas, United States, 77550|
|University of Texas Medical Branch|
|Galveston, Texas, United States, 77555-0209|
|Study Chair:||Randall Urban||University of Texas|