Ignite Creation Date:
2024-05-05 @ 5:04 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00373386
Status:
COMPLETED
Last Update Posted:
2018-05-30
First Post:
2006-09-07
Brief Title:
Growth Hormone and Endothelial Function in Children
Sponsor:
Ohio State University
Organization:
Ohio State University
Study Overview
Official Title:
Growth Hormone and Endothelial Function in Children
Status:
COMPLETED
Status Verified Date:
2017-09
Last Known Status:
None
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:
Objective This study is designed to determine whether growth hormone treatment in children 8 to 18 years of age alters function of the lining of the arteries This may play a role in increasing or decreasing the risk of heart disease
Methods Twenty children for whom growth hormone therapy will be otherwise provided will be studied before and 3 months after starting growth hormone Subjects can be on other hormonal replacements but no other medications
Each study will be done in the fasting state The blood vessel function will be determined by measuring the change in forearm blood flow before and after blocking flow to the arm for 5 minutes Blood will be drawn after the test to measure glucose insulin and fats
Methods Twenty children for whom growth hormone therapy will be otherwise provided will be studied before and 3 months after starting growth hormone Subjects can be on other hormonal replacements but no other medications
Each study will be done in the fasting state The blood vessel function will be determined by measuring the change in forearm blood flow before and after blocking flow to the arm for 5 minutes Blood will be drawn after the test to measure glucose insulin and fats
Detailed Description:
The purpose of the research is to learn more about how the lining of arteries in the body called the endothelium is affected by growth hormone treatment in children and adolescents Poor function by the blood vessels is associated with increased risk of heart disease or stroke This research is being done because growth hormone treatment has been shown to make the endothelium work better in adults Growth hormone treatment may have the same or different effects in children because the dose is larger in children
Children between 8 and 18 years who are to be started on growth hormone will be eligible to participate Blood vessel function will be studied before starting growth hormone and 3 months after This will be done by measuring blood flow to the arm before and after 5 min of stopping blood flow to the arm The three months of growth hormone will be given free
Children between 8 and 18 years who are to be started on growth hormone will be eligible to participate Blood vessel function will be studied before starting growth hormone and 3 months after This will be done by measuring blood flow to the arm before and after 5 min of stopping blood flow to the arm The three months of growth hormone will be given free
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None