Phase I/II Study of Neuroendocrine Dysfunction in Patients With Closed Head Injuries
Primary Purpose
Brain Injury
Status
Unknown status
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Brain Injury focused on measuring brain injury, neurologic and psychiatric disorders, rare disease
Eligibility 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
Sites / Locations
- Transitional Learning Community
- University of Texas Medical Branch
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00006271
First Posted
September 11, 2000
Last Updated
June 23, 2005
Sponsor
National Center for Research Resources (NCRR)
Collaborators
University of Texas
1. Study Identification
Unique Protocol Identification Number
NCT00006271
Brief Title
Phase I/II Study of Neuroendocrine Dysfunction in Patients With Closed Head Injuries
Study Type
Observational
2. Study Status
Record Verification Date
December 2003
Overall Recruitment Status
Unknown status
Study Start Date
January 1997 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Center for Research Resources (NCRR)
Collaborators
University of Texas
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Injury
Keywords
brain injury, neurologic and psychiatric disorders, rare disease
7. Study Design
Enrollment
100 (false)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Randall Urban
Organizational Affiliation
University of Texas
Official's Role
Study Chair
Facility Information:
Facility Name
Transitional Learning Community
City
Galveston
State/Province
Texas
ZIP/Postal Code
77550
Country
United States
Facility Name
University of Texas Medical Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555-0209
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Phase I/II Study of Neuroendocrine Dysfunction in Patients With Closed Head Injuries
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