Phase I/II Study of Neuroendocrine Dysfunction in Patients With Closed Head Injuries - Full Text View

Purpose

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.

Condition

Brain Injury

MedlinePlus related topics:

Traumatic Brain Injury

U.S. FDA Resources

Study Type:	Observational
Study Design:	Screening

Further study details as provided by National Center for Research Resources (NCRR):

Estimated Enrollment:	100
Study Start Date:	January 1997

Detailed Description:

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006271

Locations


United States, Texas
	Transitional Learning Community
	Galveston, Texas, United States, 77550
	University of Texas Medical Branch
	Galveston, Texas, United States, 77555-0209

Sponsors and Collaborators

National Center for Research Resources (NCRR)

University of Texas

Investigators


Study Chair:	Randall Urban	University of Texas

More Information

Study ID Numbers:	199/15377, UTMB-96-422, UTMB-GCRC-453
First Received:	September 11, 2000
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00006271
Health Authority:	United States: Federal Government

Keywords provided by National Center for Research Resources (NCRR):

brain injury

neurologic and psychiatric disorders

rare disease

Study placed in the following topic categories:

Craniocerebral Trauma

Mental Disorders

Wounds and Injuries

Rare Diseases

Central Nervous System Diseases

Disorders of Environmental Origin

Head Injuries, Closed

Wounds, Nonpenetrating

Trauma, Nervous System

Brain Diseases

Brain Injuries

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on December 03, 2008

Sponsors and Collaborators:	National Center for Research Resources (NCRR) University of Texas
Information provided by:	National Center for Research Resources (NCRR)
ClinicalTrials.gov Identifier:	NCT00006271