Phase I/II Study of Neuroendocrine Dysfunction in Patients With Closed Head Injuries

The recruitment status of this study is unknown because the information has not been verified recently.

Verified December 2003 by National Center for Research Resources (NCRR). Recruitment status was Active, not recruiting

First Received on September 11, 2000. Last Updated on June 23, 2005 History of Changes

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

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

Study Type:	Observational
Study Design:	Primary Purpose: Screening

Resource links provided by NLM:

MedlinePlus related topics: Head Injuries Traumatic Brain Injury

U.S. FDA Resources

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

No publications provided

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

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

brain injury
neurologic and psychiatric disorders
rare disease

Additional relevant MeSH terms:

Head Injuries, Closed
Brain Injuries
Craniocerebral Trauma
Trauma, Nervous System
Nervous System Diseases

Wounds and Injuries
Wounds, Nonpenetrating
Brain Diseases
Central Nervous System Diseases

ClinicalTrials.gov processed this record on February 09, 2012