Growth Hormone and Endothelial Function in Children
Information source: Ohio State University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Growth Hormone Deficiency; Panhypopituitarism; Short Stature
Intervention: growth hormone (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Ohio State University Official(s) and/or principal investigator(s):
Robert P Hoffman, MD, Study Chair, Affiliation: Ohio State University
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.
Clinical Details
Official title: Growth Hormone and Endothelial Function in Children
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Change in Reactive Hyperemic response after 3 months of growth hormone
Secondary outcome: Glucose, Insulin, lipid measurements
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.
Eligibility
Minimum age: 8 Years.
Maximum age: 18 Years.
Gender(s): Both.
Criteria:
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)
Locations and Contacts
Ohio State University, Columbus, Ohio 43210, United States
Additional Information
Starting date: January 2005
Last updated: June 27, 2008
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