Growth Hormone and Endothelial Function in Children

This study has been completed.
Sponsor:
Collaborator:
Nationwide Children's Hospital
Information provided by:
Ohio State University
ClinicalTrials.gov Identifier:
NCT00373386
First received: September 7, 2006
Last updated: June 27, 2008
Last verified: June 2008

September 7, 2006
June 27, 2008
January 2005
June 2007   (final data collection date for primary outcome measure)
Change in Reactive Hyperemic response after 3 months of growth hormone [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Change in Reactive Hyperemic response after 3 months of growth hormone
Complete list of historical versions of study NCT00373386 on ClinicalTrials.gov Archive Site
Glucose, Insulin, lipid measurements [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Glucose, Insulin, lipid measurements
Not Provided
Not Provided
 
Growth Hormone and Endothelial Function in Children
Growth Hormone and Endothelial Function in Children

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.

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.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Growth Hormone Deficiency
  • Panhypopituitarism
  • Short Stature
Drug: growth hormone
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
December 2007
June 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • isolated growth hormone deficiency (peak growth hormone level less than 10 ng/ml in response to arginine-insulin stimulation with cortisol responses and thyroid function tests), panhypopituitarism with appropriate thyroxine (normal free T4 level) and cortisol replacement (8-12 mg/m2/day) and non classic growth hormone deficiency (growth velocity less than 5 cm/year; peak growth hormone >10 ng/ml).

Exclusion Criteria:

  • Taking medications other than the appropriate hormonal replacement(L-thyroxine, cortisol, estrogen or testosterone, DDAVP)
Both
8 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00373386
Peds15
No
Robert Hoffman, Research Institute at Nationwide Children's Hospital
Ohio State University
Nationwide Children's Hospital
Study Chair: Robert P Hoffman, MD Ohio State University
Ohio State University
June 2008

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