Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006271
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2000-09-11
Brief Title:
Phase III Study of Neuroendocrine Dysfunction in Patients With Closed Head Injuries
Sponsor:
National Center for Research Resources NCRR
Organization:
National Center for Research Resources NCRR
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2003-12
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UTMB-GCRC-453 | None | None | None |
| UTMB-96-422 | None | None | None |