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Home > "P" Clinical Trials Conditions > Phase I/II Study of Neuroendocrine Dysfunction in Patients With Closed Head Injuries  Phase I/II Study of Neuroendocrine Dysfunction in Patients With Closed Head Injuries
Phase I/II Study of Neuroendocrine Dysfunction in Patients With Closed Head Injuries
For Condition: Brain Injury
Status: Recruiting
Sponsor(s): National Center for Research Resources (NCRR) , University of Texas
Synopsis: OBJECTIVES: I. Determine the incidence of neuroendocrine dysfunction in patients with closed head injuries admitted to the Transitional Learning Community in Galveston, Texas, for rehabilitation.
Details: 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.
Eligibility:
Study Type: Observational, Screening
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Closed head injury that occurred at least 3 months ago - Must be admitted to the Transitional Learning Community in Galveston, Texas, for rehabilitation --Prior/Concurrent Therapy-- - No concurrent oral contraceptives or hormone replacement therapy --Patient Characteristics-- - Mentally competent - No legal guardian - Not pregnant or nursing
Total Enrollment: 100
Location and Contact Information:
Overall Study Official:
RandallUrban, Study Chair, University of Texas
University of Texas Medical Branch *Recruiting*
Galveston, Texas, 77555-0209
United States
Recruiting Randall Urban 409-772-1176
Transitional Learning Community *Recruiting*
Galveston, Texas, 77550
United States
Recruiting Brent Masel 409-762-6661
Additional Information:
Study ID Numbers: 199/15377; UTMB-96-422,UTMB-GCRC-453
Study Start Date: January 1997
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006271
Other Brain Injury Studies:
1. Neuropsychiatric Evaluation of Healthy Volunteers and Adults with Schizophrenia
2. Genotype Influence on Recovery After Traumatic Brain Injury
3. Antenatal Phenobarbital to Prevent Neonatal Intracranial Hemorrhage
4. Phase I/II Study of Neuroendocrine Dysfunction in Patients With Closed Head Injuries
5. Study of the Approximate Entropy of Adrenocorticotropic Hormone and Cortisol Secretion in Patients With Head Injury
Related Studies:
Other Brain Injury Clinical Trials
Other Texas Clinical Trials
Other Galveston Clinical Trials
Phase I/II Study of Neuroendocrine Dysfunction in Patients With Closed Head Injuries
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