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

NCT ID: NCT00006271

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

1997-01-31

Brief Summary

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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

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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.

Conditions

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Brain Injury

Keywords

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brain injury neurologic and psychiatric disorders rare disease

Eligibility Criteria

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Inclusion 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Texas

OTHER

Sponsor Role collaborator

National Center for Research Resources (NCRR)

NIH

Sponsor Role lead

Principal Investigators

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Randall Urban

Role: STUDY_CHAIR

University of Texas

Locations

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Transitional Learning Community

Galveston, Texas, United States

Site Status

University of Texas Medical Branch

Galveston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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UTMB-96-422

Identifier Type: -

Identifier Source: secondary_id

UTMB-GCRC-453

Identifier Type: -

Identifier Source: secondary_id

199/15377

Identifier Type: -

Identifier Source: org_study_id