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

Tracking Information

First Received Date ^ICMJE

September 11, 2000

Last Updated Date

June 23, 2005

Start Date ^ICMJE

January 1997

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00006271 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Brief 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.

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.

Study Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Screening

Condition ^ICMJE

Brain Injury

Intervention ^ICMJE

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

100

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00006271

Responsible Party

Study ID Numbers ^ICMJE

199/15377, UTMB-96-422, UTMB-GCRC-453

Study Sponsor ^ICMJE

National Center for Research Resources (NCRR)

Collaborators ^ICMJE

University of Texas

Investigators ^ICMJE

Study Chair:

Randall Urban

University of Texas

Information Provided By

National Center for Research Resources (NCRR)

Verification Date

December 2003

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP