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

Brain Injury Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00006271
• Other study ID #: 199/15377
• Secondary ID: UTMB-96-422UTMB-
• Status: Active, not recruiting
• Phase: N/A
• First received: September 11, 2000
• Last updated: June 23, 2005
• Start date: January 1997

Study information

• Verified date: December 2003
• Source: National Center for Research Resources (NCRR)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Screening

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injury

Locations

Country	Name	City	State
United States	Transitional Learning Community	Galveston	Texas
United States	University of Texas Medical Branch	Galveston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
National Center for Research Resources (NCRR)	University of Texas

Country where clinical trial is conducted

United States,